Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015990335

FEI Number

3015990335

Entity Name

EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. VE TIC. A.S

City/State/Country

Ergene Tekirdag, TR

Establishment Address

Karamehmet MH. Avrupa Serbest Bolgesi, Adnan Arisoy Bulvari NNo: 11/Z02, Ergene Tekirdag 59930, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. vE TIC. A.S (Owner Number: 10080092)

Owner / Operator Contact Address

Karamehmet MH. Avrupa Serbest Bolgesi, Adnan Arisoy Bulvari No: 11/Z02, Ergene, TR-59 59930, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Earnet -Smart E HPn - Blue - 8682549135973 Earnet -Smart P+ Box - Black - Right - 8682549136390 Earnet -Tie Pr - Ice - 8682549136192 Earnet - Tie U - Ice - 8683873080106 Earnet -Smart E FO - Black - 8682549136321 Earnet -Smart P+ Micro - Black Left - 8683873084104 Earnet -Smart P+ HPn - Black - 8682549136444 Helix -TIE 400 - Ice - 8682549132682 Helix - TIE 400 - Ice - 8682549132682 Helix - TIE 100 - Ice - 8682549132583 Earnet -Smart E Box - Black - Right - 8682549136598 Earnet -Smart Pr SPn - Chocolate Brown - 8682549135812 Earnet -Smart P+ MicP - Black Left - 8683873084098 Earnet - Tie E - Ice - 8682549136147 Helix - TIE 300 - Ice - 8683873080588 Earnet -Smart E Box - Black - Left - 8682549136604 Earnet -Smart P+ Micro - Black Right - 8683873084111 Earnet - Tie E Champagne - 8682549133870 Helix - Tie 300 Champagne - 8682549130411 Earnet -Smart Pr RIC (RIC) - Grey - 8683873081424 Helix -TIE 100 - Ice - 8682549132583 Earnet -Smart Pr HPn - Chocolate Brown - 8682549135850 Helix -Force 100 ITH-D - Left - 8683873080205 Helix -Tie 100 - Beige - 8683873081042 Earnet -Smart E HPn - Chocolate Brown - 8682549135836 Earnet -Smart P+ Box - Black - Left - 8682549136406 Anaton - TIE 60 Champagne - 8682549137229 Earnet - Tie P+ - Black - 8683873080908 Anaton - TIE 90 Champagne - 8682549137250 Helix -TIE 200 - Black - 8682549132569 Helix - Tie 400 Champagne - 8682549130428 Anaton - TIE 60 Silver - 8682549139292 Earnet - Tie Pr - Ice - 8682549136192 Earnet -Smart U HPn - Chocolate Brown - 8682549135843 Earnet -Smart Pr SPn - Ice - 8683873081158 Earnet -Tie X Pr - Black - 8683873080571 Helix -Force 400 HP - Grey - 8683873081318 Anaton - TIE 70 Champagne - 8682549137236 Earnet -Smart E Micro - Black - Right - 8682549136093 Earnet -Smart U HPn - Pink - 8682549136086 Helix -Force 200 RIE (RIC) - Black - 8683873080847 Earnet -Smart E HPn - Black - 8682549136864 Earnet -Smart P+ FO - Black - 8682549136345 Helix -Force 100 SP - Ice - 8683873081509 Earnet - Tie U Champagne - 8682549133887 Earnet -Smart Pr MicP - Black Left - 8683873080557 Helix -Force 200 Box -Black Left - 8682549132606 Earnet - Tie P+ - Beige - 8683873080083 Earnet -Smart U SPn - Pink - 8682549135966 Helix -Force 200 SP - Pink - 8683873081356 Helix -Force 100 SP -Black - 8682549132798 Earnet -Smart U RIC (RIC) - Black - 8683873080496 Helix -Force 200 SP - Ice - 8683873081516 Helix -Force 100 SP -Grey - 8683873080465 Earnet -Smart E HPn - Pediatric Beige - 8683873081370 Earnet -Smart E RIC (RIC) - Black - 8683873080229 Earnet -Tie E - Beige - 8683873080625 Helix -TIE 300 - Ice - 8683873080588 Earnet -Smart Pr FO - Black - 8682549136338 Helix -Force 100 ITH-D - Right - 8683873080199 Helix -Tie 100 - Black - 8683873081172 Earnet - Tie U - Beige - 8683873080090 Helix - TIE 200 - Black - 8682549132569 Anaton - Tie 90 - Beige - 8683873081325 Helix -TIE 200 - Beige - 8683873080397 Earnet -Smart Pr HPn - Blue - 8682549135997 Earnet -Smart Pr SPn - Blue - 8682549135928 Helix -Force 100 ITH-P - Left - 8682549130619 Helix -Tie 200 - Ice - 8683873080113 Earnet - Tie Pr Champagne - 8682549133894 Anaton -Tie 90 - Beige - 8683873081325 Earnet -Smart P+ SPn - Chocolate Brown - 8682549135829 Anaton - TIE 90 Silver - 8682549139322 Helix - Tie 200 - Ice - 8683873080113 Helix - Tie 100 Champagne - 8682549130398 Earnet -Smart Pr MicP - Black Right - 8683873080540 Helix -Force 300 CIC-P - Black - Left - 8683873081073 Helix -Force 200 Box -Black Right - 8682549132590 Earnet - Tie P+ Champagne - 8682549133900 Earnet -Smart E MicP - Black - Left - 8682549136062 Earnet -Smart U HPn - Pediatric Transparent - - 8683873080182 Earnet -Smart P+ HPn - Blue - 8682549136000 Helix -Force 200 HP - Chocolate Brown - 8683873081486 Earnet -Smart E SPn - Pediatric Beige - 8683873081363 Earnet -Smart E SPn - Chocolate Brown - 8682549135805 Earnet -Tie P+ - Black - 8683873080908 Earnet -Smart U HPn - Blue - 8682549135980 Earnet -Smart Pr SPn - Pink - 8683873081127 Helix -Force 100 HP - Grey - 8683873080304 Anaton - TIE 70 Silver - 8682549139308 Earnet -Smart E SPn - Pink - 8683873081240 Earnet -Smart E SPn - Blue - 8682549135911 Earnet -Tie E - Ice - 8682549136147 Earnet -Smart U HPn - Pediatric Blue - 8683873080564 Earnet -Smart Pr Box - Black - Left - 8682549136383 Helix -Force 100 HP - Black - 8682549132576 Anaton - TIE 80 Champagne - 8682549137243 Earnet -Smart Pr Box - Black - Right - 8682549136376 Helix -Force 100 HP -Chocolate Brown - 8683873080403 Helix -TIE X 100 - Chocolate Brown - 8682549132668 Anaton - TIE 80 Silver - 8682549139315 Earnet -Smart E SPn - Champagne - 8683873080472 Earnet -Tie P+ - Beige - 8683873080083 Helix -Force 300 HP - Grey - 8683873084036 Earnet -Smart Pr HPn - Grey - 8683873081493 Helix -Force 300 CIC-P - Black - Right - 8683873081066 Helix -Force 100 SP -Champagne - 8682549132675 Earnet -Smart E Micro - Black - Left - 8682549136109 Earnet -Smart U HPn - Black - 8682549136420 Helix -Force 200 SP - Champagne - 8683873081523 Earnet -Smart Pr HPn - Black - 8682549136437 Earnet -Smart P+ MicP - Black Right - 8683873084081 Helix -Tie X 200 - Black - 8683873081530 Earnet - Tie E- Beige - 8683873080625 Helix - Tie 200 Champagne - 8682549130404 Earnet -Smart U Box - Black - Left - 8682549136369 Earnet -Tie U - Ice - 8683873080106 Helix -Force 300 SP - Pink - 8683873081233 Earnet -Smart E MicP - Black - Right - 8682549136055 Earnet -Smart U HPn - Pediatric Transparent - - 8683873080175 Earnet -Smart P+ HPn - Chocolate Brown - 8682549135867 Helix -Force 100 SP - Pink - 8683873081295 Earnet -Smart U Box - Black - Right - 8682549136352 Earnet -Smart Pr RIC (RIC) - Black - 8683873081110 Earnet -Tie U - Beige - 8683873080090 Helix -Force 400 HP - Black - 8683873084043 Earnet -Smart E FO - Chocolate Brown - 8683873081134 Earnet -Smart E RIC (RIC) - Chocolate Brown - 8682549135959 Earnet -Smart P+ SPn - Blue - 8682549135935 Helix - TIE 200 - Beige - 8683873080397 Anaton -Nida M 90 MicP - Black - Left - 8683873083619 Anaton -Nida M 80 OPR-M - Chocolate Brown - 8683873089062 Earnet -Biyonix P+ S-P - Pink - 8683873082018 Earnet -Biyonix U MP -Left - 8685149750027 Earnet -Biyonix E RIC-M - Black - 8683873088171 Helix -Alfa W 100 S-P - Black - 8683873082711 Helix -Alfa W 300 S-P - Blue - 8683873082896 Helix -Alfa W 400 RIE-MR -Ice - 8683873085033 Anaton - TIE X 90 Silver - 8682549139391 Anaton -Nida M 90 MicP - Left - 8683873083596 Anaton -Nida M 90 MG - Right - 8685149750003 Anaton -Nida M 80 OPR-M - 8683873089048 Earnet -Biyonix P+ S-P - Chocolate Brown - 8683873081998 Earnet -Biyonix E MP Black -Left - 8683873089819 Helix -Alfa W 100 S-P - Blue - 8683873082759 Helix -Alfa W 300 S-P - Champagne - 8683873082872 Helix -Alfa W 300 RIE-M - Black - 8683873088676 Anaton -Nida M 70 MicP - Left - 8683873083510 Anaton -Nida M 80 OPR-MR -Beige - 8683873085378 Anaton -Nida M 60 OPR-M - Chocolate Brown - 8683873088966 Earnet -Biyonix Pr S-P - Chocolate Brown - 8683873081929 Earnet -Biyonix E RIC-MR -Ice - 8683873084487 Earnet -Biyonix P+ RIC-MR -Beige - 8683873084623 Earnet -Biyonix Pr MP -Left - 8683873089307 Helix -Alfa W 400 MicP - Right - 8683873082629 Helix -Alfa W 200 S-P - Champagne - 8683873082803 Helix -Alfa W 200 RIE-MR -Ice - 8683873084937 Helix -Alfa W 400 RIE-M - Champagne - 8683873088737 Anaton - TIE X 80 Silver - 8682549139384 Anaton -Nida M 80 MicP - Black - Left - 8683873083572 Anaton -Nida M 60 OPR-MR -Champagne - 8683873085293 Anaton -Nida M 80 MG -Black -Right - 8683873089581 Anaton -Nida M 70 OPR-M - Black - 8683873089024 Earnet -Biyonix P+ S-P - Ice - 8683873081974 Earnet -Biyonix E MP -Left - 8683873089796 Helix -Alfa W 100 S-P - Champagne - 8683873082735 Helix -Alfa W 300 RIE-M - Ice - 8683873088652 Anaton -Nida M 90 MicP - Right - 8683873083589 Anaton -Nida M 80 MG -Black -Left - 8683873089666 Anaton -Nida M 70 OPR-M - Champagne - 8683873089031 Earnet -Biyonix P+ S-P - Champagne - 8683873081981 Earnet -Biyonix E MP Black -Right - 8683873089802 Helix -Alfa W 100 S-P - Chocolate Brown - 8683873082742 Helix -Alfa W 300 S-P - Ice - 8683873082865 Helix -Alfa W 300 RIE-M - Chocolate Brown - 8683873088669 Anaton - TIE X 80 Champagne - 8682549137281 Anaton -Nida M 60 MicP - Left - 8683873083473 Anaton -Nida M 90 S-G - 8683873083879 Anaton -Nida M 70 OPR-MR -Ice - 8683873085330 Anaton -Nida M 60 MG - Right - 8683873089482 Anaton -Nida M 90 MG -Black -Right - 8683873089765 Earnet -Biyonix U S-P - Painted Black - 8683873084203 Earnet -Biyonix Pr RIC-MR -Ice - 8683873084586 Helix -Alfa W 300 MicP - Right - 8683873082582 Helix -Alfa W 100 RIE-M - Ice - 8683873088553 Helix -Alfa W 400 RIE-M - 8683873088690 Anaton -Nida M 90 S-G - Painted Black - 8683873084388 Anaton -Nida M 70 MG -Black -Left - 8683873089550 Earnet -Biyonix U S-P - 8683873081813 Earnet -Biyonix Pr S-P - Black - 8683873081899 Helix -Alfa W 100 MicP - Left - 8683873082513 Helix -Alfa W 400 MicP - Black - Left - 8683873082650 Helix -Alfa W 300 ITE-P - Black -Right - 8685149750355 Helix -Alfa W 200 RIE-M - Black - 8683873088621 Anaton -Nida M 60 MicP - Right - 8683873083466 Anaton -Nida M 90 MicP - Black - Right - 8683873083602 Anaton -Nida M 80 OPR-M - Ice - 8683873089055 Earnet -Biyonix P+ S-P - Blue - 8683873082001 Earnet -Biyonix U MP -Right - 8683873089826 Helix -Alfa W 100 S-P - Pink - 8683873082766 Helix -Alfa W 300 S-P - Chocolate Brown - 8683873082889 Helix -Alfa W 400 RIE-MR -Beige - 8683873085026 Helix -Alfa W 300 RIE-M - Champagne - 8683873088683 Anaton -Nida M 60 MicP - Black - Right - 8683873083480 Anaton -Nida M 70 OPR-MR -Champagne - 8683873085347 Anaton -Nida M 60 MG - Left - 8683873089499 Anaton -Nida M 90 MG -Black -Left - 8683873089772 Earnet -Biyonix Pr S-P - 8683873081882 Earnet -Biyonix Pr RIC-MR -Champagne - 8683873084593 Helix -Alfa W 300 MicP - Left - 8683873082599 Helix -Alfa W 100 S-P - Painted Black - 8683873084272 Helix -Alfa W 100 RIE-M - Chocolate Brown - 8683873088560 Helix -Alfa W 400 RIE-M - Ice - 8683873088706 Anaton - TIE X 90 Champagne - 8682549137298 Anaton -Nida M 70 S-G - Blue - 8683873083787 Anaton -Nida M 90 S-G - Champagne - 8683873083909 Earnet -Biyonix Pr MicP - Left - 8683873081592 Earnet -Biyonix E S-P - Chocolate Brown - 8683873081783 Earnet -Biyonix E RIC-M - Chocolate Brown - 8683873088164 Earnet -Biyonix P+ RIC-M - Ice - 8683873088300 Helix -Alfa W 100 RIE-MR -Ice - 8683873084883 Helix -Alfa W 200 ITE-P - Left - 8685149750300 Earnet - TIE X U Silver - 8682549134426 Anaton -Nida M 60 S-G - Chocolate Brown - 8683873083701 Anaton -Nida M 80 S-G - Ice - 8683873083824 Anaton -Nida M 80 OPR-MR -Chocolate Brown - 8683873085408 Anaton -Nida M 90 OPR-M - Ice - 8683873089109 Earnet -Biyonix U MicP - Black - Right - 8683873081646 Earnet -Biyonix U RIC-M - Chocolate Brown - 8683873088218 Helix -Alfa W 400 S-P - 8683873082919 Helix -Alfa W 200 SPn - Black - 8683873084005 Earnet - Tie X P Plus Champagne - 8682549133948 Helix - Tie X 200 - Black - 8683873081530 Anaton -Nida M 60 S-G - 8683873083664 Anaton -Nida M 80 OPR-M - Black - 8683873089079 Earnet -Biyonix P+ MicP - Left - 8683873081615 Earnet -Biyonix P+ S-P - Black - 8683873081967 Earnet -Biyonix U MP Black -Right - 8683873089277 Earnet -Biyonix E RIC-M - Champagne - 8683873088188 Helix -Alfa W 300 S-P - Pink - 8683873082902 Helix -Alfa W 400 RIE-MR -Champagne - 8683873085040 Earnet - Tie X E Champagne - 8682549133917 Anaton -Nida M 80 S-G - Painted Black - 8683873084371 Anaton -Nida M 70 OPR-MR -Beige - 8683873085323 Anaton -Nida M 90 OPR-MR -Black - 8683873085460 Anaton -Nida M 90 MG - Left - 8685149750010 Earnet -Biyonix E S-P - 8683873081745 Earnet -Biyonix U S-P - Black - 8683873081820 Earnet -Biyonix Pr RIC-MR -Beige - 8683873084579 Helix -Alfa W 200 MicP - Black - Left - 8683873082575 Helix -Alfa W 100 RIE-M - 8683873088546 Anaton - TIE X 70 Silver - 8682549139377 Helix - TIE X 400 Silver - 8682549131777 Anaton -Nida M 80 S-G - Blue - 8683873083855 Anaton -Nida M 90 OPR-MR -Ice - 8683873085439 Earnet -Biyonix Pr MicP - Black - Left - 8683873081677 Earnet -Biyonix U S-P - Chocolate Brown - 8683873081851 Earnet -Biyonix Pr RIC-M - 8683873088249 Helix -Alfa W 200 MicP - Right - 8683873082544 Helix -Alfa W 400 SPn - Black - 8683873080977 Helix -Alfa W 400 ITE-P - Left - 8685149750386 Anaton -Nida M 80 S-G - Chocolate Brown - 8683873083848 Anaton -Nida M 90 OPR-MR -Beige - 8683873085422 Earnet -Biyonix Pr MicP - Black - Right - 8683873081660 Earnet -Biyonix U RIC-M - Champagne - 8683873088232 Helix -Alfa W 100 MicP - Black - Left - 8683873082537 Helix -Alfa W 400 S-P - Champagne - 8683873082940 Helix -Alfa W 200 SPn - Transparent Blue - 8683873081271 Helix -Alfa W 400 ITE-P - Right - 8685149750362 Anaton - TIE X 60 Silver - 8682549139360 Helix - Tie X 300 Champagne - 8682549130459 Earnet - TIE X P+ Silver - 8682549134433 Helix - TIE X 200 Silver - 8682549131760 Anaton -Nida M 80 MicP - Beige - Right - 8683873083541 Anaton -Nida M 60 S-G - Black - 8683873083671 Anaton -Nida M 70 OPR-M - 8683873088997 Anaton -Nida M 90 OPR-M - Champagne - 8683873089130 Earnet -Biyonix E RIC-MR -Black - 8683873084517 Earnet -Biyonix P+ RIC-MR -Chocolate Brown - 8683873084654 Earnet -Biyonix P+ MP -Right - 8685149750058 Helix -Alfa W 200 S-P - Pink - 8683873082834 Helix -Alfa W 400 S-P - Chocolate Brown - 8683873082957 Helix -Alfa W 200 RIE-MR -Black - 8683873084968 Anaton -Nida M 70 MicP - Right - 8683873083503 Anaton -Nida M 70 OPR-MR -Black - 8683873085361 Anaton -Nida M 60 OPR-M - Ice - 8683873088959 Earnet -Biyonix Pr S-P - Champagne - 8683873081912 Earnet -Biyonix E RIC-MR -Beige - 8683873084470 Earnet -Biyonix Pr RIC-MR -Black - 8683873084616 Helix -Alfa W 300 MicP - Black - Left - 8683873082612 Helix -Alfa W 200 S-P - Ice - 8683873082797 Helix -Alfa W 200 RIE-MR -Beige - 8683873084920 Helix -Alfa W 100 RIE-M - Champagne - 8683873088584 Helix -Alfa W 400 RIE-M - Black - 8683873088720 Anaton -Nida M 90 S-G - Black - 8683873083886 Anaton -Nida M 70 MG -Black -Right - 8683873089543 Earnet -Biyonix E S-P - Painted Black - 8683873084197 Earnet -Biyonix Pr S-P - Pink - 8683873081943 Helix -Alfa W 100 MicP - Right - 8683873082506 Helix -Alfa W 400 MicP - Black - Right - 8683873082643 Helix -Alfa W 300 ITE-P - Left - 8685149750348 Helix -Alfa W 200 RIE-M - Chocolate Brown - 8683873088614 Earnet - Tie X Pr - Black - 8683873080571 Anaton -Nida M 60 MicP - Black - Left - 8683873083497 Anaton -Nida M 70 OPR-MR -Chocolate Brown - 8683873085354 Anaton -Nida M 60 MG -Black -Right - 8683873089505 Anaton -Nida M 60 OPR-M - 8683873088942 Earnet -Biyonix Pr S-P - Ice - 8683873081905 Earnet -Biyonix P+ S-P - Painted Black - 8683873084227 Earnet -Biyonix Pr RIC-MR -Chocolate Brown - 8683873084609 Helix -Alfa W 300 MicP - Black - Right - 8683873082605 Helix -Alfa W 200 S-P - 8683873082773 Helix -Alfa W 100 RIE-M - Black - 8683873088577 Helix -Alfa W 400 RIE-M - Chocolate Brown - 8683873088713 Anaton -Nida M 60 OPR-MR -Beige - 8683873085279 Anaton -Nida M 80 MG - Right - 8683873089567 Earnet -Biyonix U S-P - Ice - 8683873081837 Earnet -Biyonix Pr S-P - Painted Black - 8683873084210 Earnet -Biyonix P+ RIC-MR -Black - 8683873084661 Helix -Alfa W 100 MicP - Black - Right - 8683873082520 Helix -Alfa W 100 S-P - 8683873082704 Helix -Alfa W 200 RIE-M - Champagne - 8683873088638 Anaton -Nida M 70 MicP - Black - Right - 8683873083527 Anaton -Nida M 80 OPR-MR -Ice - 8683873085385 Anaton -Nida M 60 OPR-M - Black - 8683873088973 Anaton -Nida M 90 OPR-M - Chocolate Brown - 8683873089116 Earnet -Biyonix Pr S-P - Blue - 8683873081936 Earnet -Biyonix E RIC-MR -Champagne - 8683873084494 Earnet -Biyonix P+ RIC-MR -Ice - 8683873084630 Earnet -Biyonix Pr MP Black -Right - 8685149750034 Helix -Alfa W 200 S-P - Chocolate Brown - 8683873082810 Helix -Alfa W 200 RIE-MR -Champagne - 8683873084944 Anaton -Nida M 80 S-G - Black - 8683873083817 Anaton -Nida M 60 OPR-MR -Black - 8683873085316 Anaton -Nida M 90 OPR-MR -Chocolate Brown - 8683873085453 Earnet -Biyonix P+ MicP - Black - Left - 8683873081691 Earnet -Biyonix U S-P - Pink - 8683873081875 Earnet -Biyonix U RIC-MR -Black - 8683873084562 Earnet -Biyonix Pr RIC-M - Chocolate Brown - 8683873088263 Helix -Alfa W 200 MicP - Black - Right - 8683873082568 Helix -Alfa W 400 ITE-P - Black - Left - 8685149750409 Anaton - TIE X 70 Champagne - 8682549137274 Helix - Tie X 400 Champagne - 8682549130466 Anaton -Nida M 60 S-G - Champagne - 8683873083695 Anaton -Nida M 80 S-G - 8683873083800 Anaton -Nida M 90 OPR-M - 8683873089093 Earnet -Biyonix E MicP - Black - Left - 8683873081639 Earnet -Biyonix Pr MP -Right - 8683873089291 Earnet -Biyonix U RIC-M - Ice - 8683873088201 Helix -Alfa W 300 S-P - Painted Black - 8683873084296 Helix -Alfa W 400 RIE-MR -Black - 8683873085064 Earnet - TIE X E Silver - 8682549134570 Helix - TIE X 100 Silver - 8682549132217 Anaton -Nida M 80 MicP - Left - 8683873083558 Anaton -Nida M 60 S-G - Painted Black - 8683873084357 Anaton -Nida M 70 OPR-M - Ice - 8683873089000 Earnet -Biyonix E MicP - Right - 8683873081547 Earnet -Biyonix U RIC-MR -Beige - 8683873084524 Earnet -Biyonix P+ MP -Left - 8685149750065 Helix -Alfa W 200 S-P - Black - 8683873082780 Helix -Alfa W 400 S-P - Blue - 8683873082964 Helix -Alfa W 300 RIE-MR -Beige - 8683873084975 Earnet - Tie X Pr Champagne - 8682549133931 Anaton -Nida M 70 S-G - Pink - 8683873083794 Anaton -Nida M 90 S-G - Chocolate Brown - 8683873083916 Anaton -Nida M 60 MG -Black -Left - 8683873089512 Earnet -Biyonix P+ MicP - Right - 8683873081608 Earnet -Biyonix E S-P - Blue - 8683873081790 Earnet -Biyonix P+ RIC-M - Chocolate Brown - 8683873088317 Helix -Alfa W 100 RIE-MR -Champagne - 8683873084890 Helix -Alfa W 200 ITE-P - Black -Right - 8685149750317 Helix - TIE X 100 - Chocolate Brown - 8682549132668 Anaton -Nida M 80 MicP - Black - Right - 8683873083565 Anaton -Nida M 70 S-G - 8683873083732 Earnet -Biyonix E MicP - Left - 8683873081554 Earnet -Biyonix U RIC-MR -Ice - 8683873084531 Earnet -Biyonix P+ MP Black -Right - 8685149750072 Helix -Alfa W 200 S-P - Painted Black - 8683873084289 Helix -Alfa W 400 S-P - Pink - 8683873082971 Helix -Alfa W 300 RIE-MR -Ice - 8683873084982 Helix -Alfa W 100 ITE-P - Left - 8685149750263 Earnet - TIE X Pr Painted Black - 8682549136840 Anaton -Nida M 70 S-G - Black - 8683873083749 Anaton -Nida M 90 S-G - Blue - 8683873083923 Anaton -Nida M 70 MG - Right - 8683873089529 Earnet -Biyonix E S-P - Pink - 8683873081806 Earnet -Biyonix P+ RIC-M - Black - 8683873088324 Helix -Alfa W 100 RIE-MR -Chocolate Brown - 8683873084906 Helix -Alfa W 200 ITE-P - Black - Left - 8685149750324 Helix -Alfa W 200 RIE-M - 8683873088591 Helix - TIE X 100 Black - 8682549132316 Anaton -Nida M 90 S-G - Pink - 8683873083930 Anaton -Nida M 70 MG - Left - 8683873089536 Earnet -Biyonix E S-P - Black - 8683873081752 Earnet -Biyonix P+ RIC-M - Champagne - 8683873088331 Helix -Alfa W 400 MicP - Left - 8683873082636 Helix -Alfa W 100 RIE-MR -Black - 8683873084913 Helix -Alfa W 300 ITE-P - Right - 8685149750331 Helix -Alfa W 200 RIE-M - Ice - 8683873088607 Helix - Tie X 100 Champagne - 8682549130435 Anaton -Nida M 70 S-G - Ice - 8683873083756 Earnet -Biyonix U MicP - Right - 8683873081561 Earnet -Biyonix U RIC-MR -Champagne - 8683873084548 Earnet -Biyonix P+ MP Black -Left - 8685149750089 Earnet -Biyonix Pr RIC-M - Black - 8683873088270 Helix -Alfa W 300 S-P - 8683873082841 Helix -Alfa W 400 S-P - Black - 8683873082926 Helix -Alfa W 300 RIE-MR -Champagne - 8683873084999 Helix -Alfa W 100 ITE-P - Black -Right - 8685149750270 Earnet - TIE X Pr Silver - 8682549134563 Anaton -Nida M 80 S-G - Pink - 8683873083862 Anaton -Nida M 60 OPR-MR -Chocolate Brown - 8683873085309 Anaton -Nida M 90 OPR-MR -Champagne - 8683873085446 Earnet -Biyonix P+ MicP - Black - Right - 8683873081684 Earnet -Biyonix U S-P - Blue - 8683873081868 Earnet -Biyonix Pr RIC-M - Ice - 8683873088256 Helix -Alfa W 200 MicP - Left - 8683873082551 Helix -Alfa W 100 ITE-P - Right - 8685149750256 Helix -Alfa W 400 ITE-P - Black -Right - 8685149750393 Anaton - TIE X 60 Champagne - 8682549137267 Helix - TIE X 300 Silver - 8682549132224 Anaton -Nida M 60 S-G - Blue - 8683873083718 Anaton -Nida M 80 S-G - Champagne - 8683873083831 Anaton -Nida M 80 OPR-MR -Black - 8683873085415 Earnet -Biyonix U MicP - Black - Left - 8683873081653 Earnet -Biyonix U RIC-M - Black - 8683873088225 Helix -Alfa W 400 S-P - Ice - 8683873082933 Helix -Alfa W 200 SPn - Transparent Pink - 8683873081288 Helix -Alfa W 300 ITE-P - Black - Left - 8685149750379 Earnet - TIE X P+ Painted Black - 8682549136833 Helix - Tie X 200 Champagne - 8682549130442 Anaton -Nida M 60 OPR-MR -Ice - 8683873085286 Anaton -Nida M 80 MG - Left - 8683873089574 Anaton -Nida M 70 OPR-M - Chocolate Brown - 8683873089017 Earnet -Biyonix U S-P - Champagne - 8683873081844 Earnet -Biyonix P+ S-P - 8683873081950 Earnet -Biyonix E MP -Right - 8683873089789 Helix -Alfa W 100 S-P - Ice - 8683873082728 Helix -Alfa W 300 RIE-M - 8683873088645 Anaton -Nida M 70 S-G - Champagne - 8683873083763 Earnet -Biyonix U MicP - Left - 8683873081578 Earnet -Biyonix E S-P - Ice - 8683873081769 Earnet -Biyonix U RIC-MR -Chocolate Brown - 8683873084555 Earnet -Biyonix E RIC-M - 8683873088140 Earnet -Biyonix Pr RIC-M - Champagne - 8683873088287 Helix -Alfa W 400 S-P - Painted Black - 8683873084302 Helix -Alfa W 300 RIE-MR -Chocolate Brown - 8683873085002 Helix -Alfa W 100 ITE-P - Black - Left - 8685149750294 Anaton -Nida M 60 S-G - Ice - 8683873083688 Anaton -Nida M 70 S-G - Painted Black - 8683873084364 Anaton -Nida M 80 OPR-M - Champagne - 8683873089086 Earnet -Biyonix E MicP - Black - Right - 8683873081622 Earnet -Biyonix U MP Black -Left - 8683873089284 Earnet -Biyonix U RIC-M - 8683873088195 Helix -Alfa W 300 S-P - Black - 8683873082858 Helix -Alfa W 400 RIE-MR -Chocolate Brown - 8683873085057 Anaton -Nida M 70 S-G - Chocolate Brown - 8683873083770 Anaton -Nida M 90 S-G - Ice - 8683873083893 Earnet -Biyonix Pr MicP - Right - 8683873081585 Earnet -Biyonix E S-P - Champagne - 8683873081776 Earnet -Biyonix E RIC-M - Ice - 8683873088157 Earnet -Biyonix P+ RIC-M - 8683873088294 Helix -Alfa W 100 RIE-MR -Beige - 8683873084876 Helix -Alfa W 300 RIE-MR -Black - 8683873085019 Helix -Alfa W 200 ITE-P - Right - 8685149750287 Earnet - Tie X U Champagne - 8682549133924 Earnet - TIE X E Painted Black - 8682549136826 Earnet - TIE X U Painted Black - 8682549136857 Anaton -Nida M 70 MicP - Black - Left - 8683873083534 Anaton -Nida M 60 S-G - Pink - 8683873083725 Anaton -Nida M 80 OPR-MR -Champagne - 8683873085392 Anaton -Nida M 60 OPR-M - Champagne - 8683873088980 Anaton -Nida M 90 OPR-M - Black - 8683873089123 Earnet -Biyonix E RIC-MR -Chocolate Brown - 8683873084500 Earnet -Biyonix P+ RIC-MR -Champagne - 8683873084647 Earnet -Biyonix Pr MP Black -Left - 8685149750041 Helix -Alfa W 200 S-P - Blue - 8683873082827 Helix -Alfa W 200 RIE-MR -Chocolate Brown - 8683873084951

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2021-01-12
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2021-01-12

Official Correspondent

Damla San

US Agent Details

Margarita Morales Business: Healthcare International Partners Llc Email: maggie@hip-llc.com Phone: (786) 3602695

Related Public Records

Same Entity

EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. vE TIC. A.S

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015990335. Last updated year: 2026. Please use registration number 3015990335 when referencing this establishment in official correspondence.