Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617744

FEI Number

3006279007

Entity Name

Allwin Medical Devices Pvt. Ltd.

City/State/Country

Surat Gujarat, IN

Establishment Address

Plot No. 223, 230, and 221, Surat Special Economic Zone, Sachin, Surat Gujarat 394230, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Allwin Medical Devices (Owner Number: 9036357)

Owner / Operator Contact Address

53-CD, KANDIVALI INDUSTRIAL ESTATE, CHARKOP, KANDIVALI (W), MUMBAI, MAHARASTRA, IN-NOTA 400 104, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TRACK OS CERVICAL OS DILATOR CATHETER FIXING DISK Eagle-M Manual Single Lumen Ovum Pick Up Needle Eagle-FL Single Lumen Ovum Pick Up Needle with Flushing Line Eagle Single Lumen Ovum Pick-up Needle OPICK Double Lumen Ovum Pick Up Needle Aspiration Needle ASPI Suprapubic Puncture and Drainage Set Suprapubic Metal Tip Puncture and Drainage Set allSoft Multiloop Ureteral Stents R+ Pediatric Ureteral Stents R+ Ureteral Stents (Open Tip, Closed Tip) R+ Multiloop Ureteral Stents allSoft Ureteral Stents (Open Tip, Closed Tip) allSoft Pediatric Ureteral Stents SUL-Y - Yellow SUS-Y - Yellow SUL-V - Violet SUL- P - Pink SUS-I - Ivory SUS-B - Blue SUS-W - White SUS-R-WT - Red Weighted SUS-R - Red SUL-B - Blue SUL-G - Green SURGI BAND - Multiple Ligator SURGI BAND - Multiple Ligator Kit Stent Remover Ellick Bladder Evacuator - Plastic TUR-VAC Bladder Evacuator ELLICK Bladder Evacuator - Glass ELLIK BLADDER EVACUATOR Pull It Stent Remover Stent Remover Snare ASEPTO Bulb Irrigation Syringe TRACKFINDER Bulb Irrigator SUPREMO - Nitinol Hydrophilic Guidewire Schuller Guidewire Cobra - Nitinol Guidewire HYGUIDE Hydrophilic Guidewire Standard - Straight Tip Guidewire Lunderquist Guidewire King Cobra - Hydrophilic Nitinol Guidewire Standard - J Tip Guidewire Stylet for Pro Embryo Trans, Pro Echo Trans, and Twinkle Embryo Trans Stylet for Bulb Trans Ultra and Bulb Trans Star Echo Trans Embryo Transfer Catheter Embryo Trans Embryo Transfer Catheter Twinkle Embryo Trans Embryo Transfer Catheter Twinkle Pro Embryo Trans Embryo Transfer Catheter with Stylet Pro Echo Trans Embryo Transfer Catheter Soft Obturator for Pro Embryo Trans Soft Obturator for Twinkle Pro Embryo Trans Twinkle Pro Embryo Transfer Catheter Bulb Trans Star Embryo Transfer Catheter Soft Obturator for Pro Echo Trans Stylet for Embryo Trans, Echo Trans, Twinkle Embryo Trans Pro Embryo Trans Embryo Transfer Catheter Bulb Trans Ultra Embryo Transfer Catheter Trial Transfer Catheter for Embryo Trans Pro Embryo Trans Embryo Transfer Catheter with Stylet Twinkle Pro Embryo Trans Embryo Transfer Catheter with Soft Obturator Trial Transfer Catheter for Echo Trans Aspi Hydrophobic Filter Set - ASP-HFS Aspi Suction Bottle with Connector - ASP-SB Aspi Suction Line with Luer Lock Connectors - ASP - SL AspiPump Foot Switch - ASP - FS AspiPump 90D - ASPI-90D Urine Bag Connector Toomey Syringe Ureteral Catheters - all Flex Ureteral Catheters - Krait Auto Core Biopsy Needle SPEEDO Biopsy Needle PRONTO Semi-Auto Biopsy Needle With Coax Needle Ultracore Biopsy Needle - Manual STONE BASKET Intra Uterine Insemination Catheter with Malleable Stylet Intra Uterine Insemination Catheter Intra Uterine Insemination Catheter Shorty Intra Uterine Insemination Catheter Duo Intra Uterine Insemination Catheter Curved Contistrap Male Incontinence Clamp BREAST LOCALIZATION NEEDLE Re-Entry Malecot Catheter Percutaneous Nephrostomy Drainage Set - Malecot Percutaneous Nephrostomy Catheter - Pigtail Percutaneous Nephrostomy Drainage Set - ULTIMA Percutaneous Nephrostomy Drainage Set - Pigtail Percutaneous Nephrostomy Catheter - ULTIMA ULTIMA Direct Puncture Drainage Set Percutaneous Nephrostomy Catheter - Malecot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2022-02-02
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2007-07-31
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2020-03-27
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2018-09-11
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-01-10
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2022-02-03
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2018-09-11
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2009-02-27
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2007-07-31
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-09-11
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2018-09-11
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2018-09-11
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2020-08-13
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2025-04-07
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2018-09-11
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2021-03-01
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2023-09-21
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2018-09-11
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2007-07-31
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2020-04-02
MFD	Cannula, Intrauterine Insemination	Obstetrics/Gynecology	Class 2	884.5250	2020-04-02
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2018-09-11
MIJ	Needle, Tumor Localization	General, Plastic Surgery	Class 1	878.4800	2007-07-31
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2018-09-11

Official Correspondent

Rakhee Oza

US Agent Details

Dhiren Mehta Business: Allwin Medical Devices Inc. Email: info@allwinmedical.com Phone: (714) 5721709

Related Public Records

Same Entity

Allwin Medical Devices

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
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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Z-0040-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
Z-0041-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617744. Last updated year: 2026. Please use registration number 9617744 when referencing this establishment in official correspondence.