Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005987240

FEI Number

3005987240

Entity Name

ALLWIN MEDICAL DEVICES, INC.

City/State/Country

ANAHEIM, CA, US

Establishment Address

3305 E. MIRALOMA AVENUE, SUITE 176, ANAHEIM, CA 92806, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ALLWIN MEDICAL DEVICES, INC. (Owner Number: 9094082)

Owner / Operator Contact Address

3305 E. Miraloma Ave, SUITE176, Anaheim, CA 92806, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pro Echo Trans Embryo Transfer Catheter Twinkle Pro Embryo Trans Embryo Transfer Catheter Bulb Trans Ultra Embryo Transfer Catheter Soft Obturator for Twinkle Pro Embryo Trans Embryo Transfer Catheter Trial Transfer Catheter for Echo Trans 23cm Trial Transfer Catheter for Echo Trans 18cm Twinkle Embryo Trans Embryo Transfer Catheter 18cm Embryo Trans Embryo Transfer Catheter 18cm Pro Embryo Trans Embryo Transfer Catheter Trial Transfer Catheter for Embryo Trans 23cm Bulb Trans Star Embryo Transfer Catheter Soft Obturator for Pro Echo Trans Embryo Transfer Catheter ECHO TRANS Embryo Transfer Catheter 18cm Soft Obturator for Pro Embryo Trans Embryo Transfer Catheter Trial Transfer Catheter for Twinkle Embryo Trans 18cm Trial Transfer Catheter for Embryo Trans 18cm Trial Transfer Catheter for Twinkle Embryo Trans 23cm PRO-PASS STAR Embryo Transfer Catheter with STYLET PRO-PASS STAR Embryo Transfer Catheter PRO-PASS ECHO TRANS Embryo Transfer Catheter with Stylet PRO-PASS TWINKLE Embryo Transfer Catheter PRO-PASS ECHO TRANS Embryo Transfer Catheter PRO-PASS STAR Embryo Transfer Catheter with soft obturator PRO-PASS Embryo Transfer Catheter with Stylet Trial Transfer Catheter for Pro-Pass Star Embryo Transfer Catheter Stylet for Pro-Pass Embryo Transfer Catheter Stylet for Pro-Pass Twinkle Embryo Transfer Catheter PRO-PASS ECHO TRANS Embryo Transfer Catheter with Soft Obturator Stylet for Twinkle Embryo Trans Embryo Transfer Catheter 18cm Trial Transfer Catheter for Pro-Pass Twinkle Embryo Transfer Catheter PRO-PASS TWINKLE Embryo Transfer Catheter with Stylet Pro Embryo Trans Embryo Transfer Catheter with Stylet Bulb Trans Star Plus Embryo Transfer Catheter Twinkle Pro Embryo Trans Embryo Transfer Catheter with Stylet E CATH Embryo Transfer Catheter 18cm SPARKLE VIEW Embryo Transfer Catheter 23cm Stylet for Bulb Trans Ultra Embryo Transfer Catheter PRO ECHO TRANS Embryo Transfer Catheter with Stylet E CATH Embryo Transfer Catheter 23cm LOTUS ULTRA Embryo Transfer Catheter- Bulb Tip Stylet for Pro Echo Trans Embryo Transfer Catheter Stylet for Echo Trans Embryo Transfer Catheter 18cm PRO ECHO TRANS Embryo Transfer Catheter with Soft Obturator Embryo Trans Embryo Transfer Catheter 23cm Soft Obturator for Pro-Pass Embryo Transfer Catheter LOTUS STAR Embryo Transfer Catheter- Bulb Tip Soft Obturator for Pro-Pass Star Embryo Transfer Catheter SPARKLE VIEW Embryo Transfer Catheter 18cm PROCATH Embryo Transfer Catheter Stylet for Embryo Trans Embryo Transfer Catheter 18cm Stylet for Introducing Catheter with Outer Sheath 18cm ECHO VIEW Embryo Transfer Catheter 23cm PRO-PASS Embryo Transfer Catheter Stylet for Twinkle Pro Embryo Trans Embryo Transfer Catheter Stylet for Twinkle Embryo Trans Embryo Transfer Catheter 23cm PRO ECHO VIEW Embryo Transfer Catheter PRO-PASS Embryo Transfer Catheter with Soft Obturator PRO-PASS TWINKLE Embryo Transfer Catheter with Soft Obturator Pro Embryo Trans Embryo Transfer Catheter with Soft Obturator SPARKLE PRO VIEW Embryo Transfer Catheter ECHO VIEW Embryo Transfer Catheter 18cm ECHO TRANS Embryo Transfer Catheter 23cm Soft Obturator for Pro-Pass Twinkle Embryo Transfer Catheter Twinkle Pro Embryo Trans Embryo Transfer Catheter with Soft Obturator Stylet for Pro-Pass Star Embryo Transfer Catheter Stylet for Pro Embryo Trans Embryo Transfer Catheter Stylet for Echo Trans Embryo Transfer Catheter 23cm Stylet for Embryo Trans Embryo Transfer Catheter 23cm Bulb Trans Ultra Plus Embryo Transfer Catheter Trial Transfer Catheter for Pro-Pass Embryo Transfer Catheter Twinkle Embryo Trans Embryo Transfer Catheter 23cm Stylet for Bulb Trans Star Embryo Transfer Catheter Stylet for Introducing Catheter with Outer Sheath 23cm Flexi-Cath Dual Lumen Catheter ULTIMA Direct Puncture Drainage Set Percutaneous Nephrostomy Drainage Set - ULTIMA Percutaneous Nephrostomy Drainage Set - Pigtail Re-Entry Malecot Catheter Percutaneous Nephrostomy Drainage Set - Malecot Percutaneous Nephrostomy Catheter - Malecot Percutaneous Nephrostomy Catheter - ULTIMA Percutaneous Nephrostomy Catheter - Pigtail Bite-O Bite Block Tur-Vac Bladder Evacuator Ellick Bladder Evacuator - Glass Ellick Bladder Evacuator - Plastic SCHULLER Guidewire HYGUIDE Hydrophilic Guidewire LUNDERQUIST Guidewire COBRA Nitinol Guidewire KING COBRA Nitinol Guidewire Standard J Tip Guidewire SUPREMO Nitinol Hydrophilic Guidewire Standard Straight Tip Guidewire Femo Cath - Femoral Catheter ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line 16G, 17G, 18G OVUMPICK Double Lumen Ovum Pickup Needle 16G, 17G ACE Single Lumen Ovum Pickup Needle 16G, 17G, 18G ACE-M Manual Single Lumen Ovum Pickup Needle 16G, 17G, 18G Eagle Single Lumen Ovum Pickup Needle 17G EAGLE-FL Single Lumen Ovum Pickup Needles with Flushing Line DUALFLOW Double Lumen Ovum Pickup Needle 17G EAGLE-M Manual Single Lumen Ovum Pickup Needle ASPI Aspiration Needle 18G, 22G FALCON Single Lumen Ovum Pickup Needle 17G OPICK Double Lumen Ovum Pickup Needle ARMADA Ureteral Dilator Set ARMADA Amplatz Renal Dilator Set ARMADA Nottingham One Step Dilator Fascial Dilator Introducer Catheter Glider Amplatz Sheath Introducer Sheath ARMADA Renal Dilator URE-FLOW Irrigator TRACKFINDER Bulb Irrigator GUIDEWIRE BLN SURGI BAND - Multiple Ligator SURGI BAND - Multiple Ligator Kit U-FLEX DUO Ureteral Access Sheath U-FLEX Ureteral Access Sheath SALPINX CATH - Fallopian Tube Recanalisation And Set HYSTERO CATH - Hystero Salpinogography Catheter and Set Retrieval Basket Retrieval Snare Retrieval Forceps Cytology Brush CONTISTRAP Male Incontinence Clamp Suprapubic Puncture Set Suprapubic Drainage Set Esopha - Esophageal Stent Majestick Biliary Stent Introducer Bilo - Biliary Stent System Percutaneous Transhepatic Cholangio Naso Pancreatic Draiange Catheter PAN Stents - Pancreatic Stent Stone Extraction Balloon Naso Biliary Drainage Catheter Biliary Stent Bilo Biliary Stent Biliary Dilatation Catheter Biliary Stent Double Pigtail Biliary Stent Standard PTFE Chiba Needle Initial Puncture Needle Injection Needle TLA Introducer Needle Breast Localization Needle Tur Vac Bladder Evacuator with Adaptor - TV Ellick Bladder Evacuator StoneBuster Pneumatic Lithotripter Track OS Cervical OS Dilator Pediatric Urethral Stent Nova Urethral Stent UTOB - Urinary Track Occlusion Balloon Nasal Jejunal Feeding Tube Endoscopic Nasal Jejunal Feeding Tube RGT - Replacement Gastrostomy Tube SURGI PEG - Percutaneous Endoscopic Gastronomy Tube THE SAMPLER - Endometrial Biopsy Catheter PRO-VAC Endometrial Biopsy Catheter Surgiject - Injection Needle SCN - Sclerotherapy Needle SupraSet DPD Suprapubic Metal Tip Puncture and Drainage Set Suprapubic Puncture and Drainage Set Loop Supra Set INSEMINA - Intra Uterine Insemination Catheter STUMPY - Intra Uterine Insemination Catheter CURVED - Intra Uterine Insemination Catheter TRACKABLE - Intra Uterine Insemination Catheter FLEXI - Intra Uterine Insemination Catheter CURVED Open Tip - Intra Uterine Insemination Catheter INSEMINA Open Tip - Intra Uterine Insemination Catheter FLEXI Open Tip - Intra Uterine Insemination Catheter TRACKABLE Open Tip - Intra Uterine Insemination Catheter Small Bowel Enema Catheter Decompression Tube Reusable Cleaning Brush Dispo Brush Injection Cap MaxiBite Biopsy Forcep Stent Remover Helical Stone Extractor Multiwire Stone Extractor Pediatric Ureteral Stent Open Tip Ureteral Stent Open Tip Ureteral Stent Closed Tip Mono J Urinary Diversion Ureteral Stent Open Tip Ureteral Stent Via Ureterorenoscope Closed Tip Pediatric Ureteral Stent Closed Tip Multiloop Ureteral Stent Closed Tip Mono J Urinary Diversion Ureteral Stent Closed Tip Multiloop Ureteral Stent Open Tip Ureteral Stent Via Ureterorenoscope Open Tip Ureteral Stent Intraoperative Tip NephroTrack Balloon Dilator Uretrack Ureteral Balloon Dilator TU Transuretroscopic Balloon Dilator NephroTrack Balloon Dilator with Sheath NEEDLES BIOPSY Autocore Biospy Needle Pronto Biopsy Needle Ultracore Biopsy Needle Speedo Automatic Biopy Needle Stent Remover Snare Pull-It Stent Remover Renal Dilator with Amplatz Sheath Renal Dilator Amplatz Renal Dilator Set Fascial Dilator Amplatz Sheath INSEMINA Intra Uterine Insemination Catheter Open Tip FLEXI Intra Uterine Insemination Catheter Open Tip FLEXI Intra Uterine Insemination Catheter INSEMINA Intra Uterine Insemination Catheter CURVED Intra Uterine Insemination Catheter Open Tip Curved STUMPY Intra Uterine Insemination Cannula TRACKABLE Intra Uterine Insemination Catheter Open Tip with Malleable Stylet TRACKABLE Intra Uterine Insemination Catheter with Malleable Stylet CURVED Intra Uterine Insemination Catheter Curved IUI-M Intra Uterine Insemination Catheter with Malleable Stylet INTEGRA Intra Uterine Insemination Catheter IUI SHORTY Intra Uterine Insemination Cannula Shorty IUI-C Intra Uterine Insemination Catheter Curved Uriflow - Uroflowmeter Cervical OS Dilator Urine Bag Connector Ectocervical & Endocervical Samplin Endocervical Sampling Brush Sonohysterography Uterine Catheter allFlex Ureteral Catheter Rigid Grasping Forcep NITIFLEX Nitinol Stone Basket Stainless Steel Flatwire & Helical Three Prong Grasping Forcep Trapper No Tip Basket Mini - Flatwire & Helical U-Perc Nitinol Stone Extractor Maestro Nitinol Tipless Stone Basket URETERAL STONE BASKET SureLock- Yellow- Vitrification Straws: SUL-Y SureStrip- Ivory- Vitrification Straws: SUS-I SureStrip- Red- Vitrification Straws: SUS-R SureStrip- Yellow- Vitrification Straws: SUS-Y Surestrip- White- Vitrification Straws: SUS-W SureLock Green- Vitrification Straws: SUL-G SureLock - Violet - Vitrification Straws - SUL-V SureLock - Pink - Vitrification Straws -SUL-P SureLock- Blue- Vitrification Straws: SUL-B SureStrip- Blue- Vitrification Straws: SUS-B SureStrip - White - Vitrification Straws - Weighted - SUS-W-WT V-Lock Vitrification Straws- Green- VL-G V-Strip Vitrification Straws- Blue- VS-B V-Lock Vitrification Starws- Yellow- VL-Y SURESTRIP - White - Vitrification Straws -Weighted Plug - SUS-W-WTP V-Strip Vitrification Straws- Red- VS-R V-Lock Vitrification Straws- Pink- VL-P SURESTRIP - Red - Vitrification Straws -Weighted Plug - SUS-R-WTP V-Lock Vitrification Straws- Blue- VL-B SureStrip - Red - Vitrification Straws - Weighted - SUS-R-WT V-Strip Vitrification Straws- White- VS-W SureStrip - Yellow - Vitrification Straws - Weighted - SUS-Y-WT SureStrip -Ivory - Vitrification Straws- Weighted - SUS-I-WT SURESTRIP - Blue - Vitrification Straws -Weighted Plug - SUS-B-WTP V-Strip Vitrification Straws- Ivory- VS-I SureStrip - Blue - Vitrification Straws - Weighted - SUS-B-WT V-Strip Vitrification Straws-Yellow- VS-Y V-Lock Vitrification Straws- Violet- VL-V SURESTRIP - Ivory - Vitrification Straws -Weighted Plug - SUS-I-WTP SURESTRIP - Yellow - Vitrification Straws -Weighted Plug - SUS-Y-WTP AspiPump 90D - ASPI 90D Aspi Hydrophobic Filter Set - ASP-HFS Aspi Suction Line with Luer Lock Connectors - ASP-SL Power Adapter & AC Plug Set - ASP-PA Aspi Foot Switch - ASP-FS Aspi Suction Bottle with Connector - ASP-SB

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2020-07-06
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-02-20
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2009-07-10
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2009-07-10
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2018-06-08
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2018-06-08
LFK	Catheter, Femoral	Gastroenterology, Urology	Class 2	876.5540	2008-02-20
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2019-11-26
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2024-07-15
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2024-07-15
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2018-06-09
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2006-10-30
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2018-05-29
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2018-06-11
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2011-11-08
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2008-02-20
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	2008-02-19
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2008-02-20
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2018-06-09
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2008-02-19
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2008-02-19
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-02-20
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-02-19
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2008-02-20
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2023-03-29
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2008-01-24
HDD	Table, Obstetrical, Ac-Powered (And Accessories)	Obstetrics/Gynecology	Class 2	884.4900	2022-02-02
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-01-24
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-02-20
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2008-02-20
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-02-19
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2018-06-09
MFD	Cannula, Intrauterine Insemination	Obstetrics/Gynecology	Class 2	884.5250	2008-02-20
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2009-07-10
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2008-02-19
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-20
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2009-07-04
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2008-02-19
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2020-02-14
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2008-01-24
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2006-10-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-06-09
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2018-06-09
MFD	Cannula, Intrauterine Insemination	Obstetrics/Gynecology	Class 2	884.5250	2019-11-26
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2019-11-26
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2009-07-10
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2008-02-20
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2009-07-10
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2008-02-20
HFF	Aspirator, Endometrial	Obstetrics/Gynecology	Class 2	884.1060	2008-02-20
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2022-11-14
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2006-10-30
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2021-11-01
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2025-03-07

Official Correspondent

Digish Mehta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALLWIN MEDICAL DEVICES, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02
K171618	Medcomp (Dba Medical Components, Inc.)	Symetrex Long Term Hemodialysis Catheter	2017-11-16
K111817	Covidien	PALINDROME RT CHRONIC CATHETER	2011-08-30
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2013	US Endoscopy Group Inc	2	Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Z-0013-2023	Hobbs Medical, Inc.	2	Hobbs Medical Cytology Brush Catalog Number: 4204
Z-0014-2023	Hobbs Medical, Inc.	2	Hobbs Medical Cytology Brush Catalog Number: 4206
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005987240. Last updated year: 2026. Please use registration number 3005987240 when referencing this establishment in official correspondence.