Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011310592

FEI Number

3011310592

Entity Name

DGS Diagnostics Sp. z o.o

City/State/Country

Kolbaskowo Zachodniopomorskie, PL

Establishment Address

Rosowek 43, Kolbaskowo Zachodniopomorskie 72-001, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DEMANT A/S (Owner Number: 8010048)

Owner / Operator Contact Address

KONGEBAKKEN 9, --, SMORUM, DK-NOTA DK-2765, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Snap Electrode TM Electrode Tab Electrode Orion Nydiag 200 touchTymp REM440 MI 20 VisualEyes EyeSeeCam vHIT VisualEyes 515 2D-VOGfw VisualEyes 525 VisualEyes 505 Orion Comprehensive Basic Orion Autotraverse Basic USBM2.1 BG4 Vorteq Digital Light Bar Datalink AA222 GSI AUDIOscreener + GSI AUDIOscreener Affinity 2 Equinox Affinity Compact Affinity Callisto Sanibel REM Probe Tubes, type A Sanibel REM Probe Tubes, type D Type B probe tube AC 440 Module Probe tubes, type A Sanibel REM Probe Tubes, type C HIT 440 Module Race Car MI 22 MB 11 V0425B VN415M VO425M VN415B VO425 VF405M VNG System VN415 VF405 VF405B 2D-VOG Goggles 2D-VOG System MI 21 OtoWave EYESEECAM VHIT Aqua Stim Gold Tiptrodes Gold Eartip Electrode PILOT TEST Sanibel ETU Universal Electrode Cable, Blue Sanibel ETU Universal Electrode Cable, White Pinch clip cable Cable for TM ECochG electrode ETB Standard electrode cable kit Button electrode cable Jumper cable Alligator clip electrode cable Sanibel ETU Universal Electrode Cable, Yellow Sanibel ETU Universal Electrode Cable, Red Sanibel ETU Universal Electrode Cable, Black easyScreen OtoRead MB 11 with BERAPhone Probe VIOT Viot Suite AT235 MI 26 MI 24 GSI AudioSol GSI 61 AD226 GSI AudioStar Pro Amplivox 240 Wizard Ultra RA660 Avant ARC AC40 AS608 MA28 Amplivox 116 Amplivox 170 AM282 MA39 Amplivox 270 PA5 Amplivox 260 AD229 MA25 AC33 MA41 MA40 AD629 Welch Allyn AM282 MA1 Avant Stealth Audiometer MA42 Amplivox 160 GSI 17 GSI Pello GSI AMTAS MA27 MA52 MA33 Avant A2D+ Audiometer Detective GSI 18 GSI AMTAS Flex SMART TONE Audiometer Luna AD528 CCA-200mini Audiometer RA360 modelONE CCA-100mini Audiometer Fit Test Audiometer NEXT Audiometer Amplivox Otosure easyTone Amplivox PC850 IP30 Insert earphone Amplivox 270+ B71 Bone conductor headset DD45 Headset TDH39 Headset B-81 Bone conductor headset DD65 Headset CIR Insert earphone DD450 High frequency headset Equinox Evo DD65v2 Audiometric headset Touch Keyboard GSI AudioHub TEOAE25 GSI Allegro Welch Allyn MicroTymp 4 Otowave 202 Titan easyTymp Pro easyTymp GSI Novus ECLIPSE SYSTEMS EP25 EP15 IA OAE Suite EARturtle w/electrodes Infant EarCup w/ electrodes TM electrode for ECochG, starter kit Otoread EroScan Plus MI 34 GSI TympStar Sera GSI 70 Air Fx MI 44 Pediatric Eartip Kit EARturtle Pediatric OAE foam ear tip OAE Ear Tip Ear Tip Sanibel Jumbo OAE foam ear tip SnapPROBE(TM) Accessories Box Sanibel foam tip, small Assortment Box 1171 Sanibel foam tip, medium AOT Ear Tip Infant Ear Tip A ANA Ear Tip Infant Ear Tip B Preemie Ear Tip Ear Tip, infant MT4 Ear Tip Assortment Box BET55 ADI Ear tip sample kit Assortment Box 162 Sample bag - AuDX and OAE foam tips Sanibel foam tip, large Assortment Box Amplivox Ear Tip, flanged Assortment box 1154 Assortment Box 1161 Ear Tip, OAE-4 AuDX Ear Tip Ear Tip, OAE-3 Sanibel ADI Scre. Ear Tip kit Ear Tip, mushroom Sanibel foam tip sample kit Ear Tip, umbrella Sanibel ADI Ear Tip kit Adult OAE foam ear tip Assortment Box BET25 Ear tips 8 - 15 mm mushroom EarCup GSI Corti Welch Allyn OAE Foam ear tip, 18 mm, ER10C Foam ear tip, 10 mm, ER1/ER2 Ear tip, ER10C-06 Ear tip, ER10C-03 ER-2 Insert Earphones Ear tip, ER10C-05 Foam ear tip, 13 mm, ER10B+ Foam ear tip, 13 mm, ER10C Ear tip, ER10C-04 Foam ear tip, 10 mm, ER10C Foam ear tip, 13 mm, ER1/ER2 MT10 Lyra Audera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2011-11-11
LXV	Apparatus, Vestibular Analysis	Unknown	Class U	N/A	2011-03-07
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2016-11-21
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2026-03-25
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2014-03-13
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-08-05
GWN	Nystagmograph	Neurology	Class 2	882.1460	2020-11-06
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2014-03-13
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2011-12-29
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2011-12-29
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2020-04-28
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2007-12-14
GWN	Nystagmograph	Neurology	Class 2	882.1460	2008-12-18
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-01-11
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
GWN	Nystagmograph	Neurology	Class 2	882.1460	2014-04-15
ETP	Stimulator, Caloric-Water	Ear, Nose, Throat	Class 1	874.1800	2013-08-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-05-23
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2013-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-01-11
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2026-03-25
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2013-01-14
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2026-03-25
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2017-08-30
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2017-08-30
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2014-03-13
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2014-03-28
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2011-03-24
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2015-12-14
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	1994-09-21
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2026-03-25
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2008-12-18
PTP	Tympanometer, Exempt	Ear, Nose, Throat	Class 2	874.1090	2018-06-26
NAS	Tympanometer	Ear, Nose, Throat	Class 2	874.1090	2021-12-01
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2011-11-11
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2026-03-25
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2017-10-20
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2017-10-20
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2008-12-18
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2008-12-18
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2017-10-24
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2018-03-13
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2018-03-13
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2013-04-17
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-04-17
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2025-08-05
KHH	Stimulator, Caloric-Air	Ear, Nose, Throat	Class 1	874.1800	2013-08-22
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-01-11
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	Class 1	874.1100	2021-07-22
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2018-05-14
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2024-04-23
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2007-04-02
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2019-07-17
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2014-03-18
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2014-03-18

Official Correspondent

No official correspondent registered.

US Agent Details

Brandon Bell Business: Grason-Stadler Email: bnbl@grason-stadler.com Phone: (952) 9476097

Related Public Records

Same Entity

DEMANT A/S

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3032579106	ITSA Medical	Vallauris Alpes-Maritimes, FR
3017441596	Demant Operations, S.a. De C.v.	Tijuana Baja California, MX
2240713	OTICON, INC.	SOMERSET, NJ, US
3002504821	MAICO Diagnostics GmbH	Berlin, DE
3005465494	Oticon A/S	Smorum Hovedstaden, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011310592. Last updated year: 2026. Please use registration number 3011310592 when referencing this establishment in official correspondence.