Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005483737

FEI Number

3005483737

Entity Name

DEGANIA MEDICAL DEVICES PVT. LTD.

City/State/Country

GURGAON Haryana, IN

Establishment Address

251 & 275 SEC-6 IMT MANESAR, GURGAON Haryana 122050, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

QMD (Owner Number: 8030107)

Owner / Operator Contact Address

DEGANIA BET, Degania Bet, IL-Z 1513000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gastrostomy Replacement Tube with Lubricant Jelly Cervical Ripening Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PRP	Balloon Gastrostomy Tube Kit	Gastroenterology, Urology	Class 2	876.5980	2026-02-18
HDY	Dilator, Cervical, Hygroscopic-Laminaria	Obstetrics/Gynecology	Class 2	884.4260	2011-09-12
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-12-05
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2006-08-07
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2006-02-17
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2000-12-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-12-05
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2007-12-05

Official Correspondent

Tal Gafni

US Agent Details

Angie Doe Email: adoe@qmd.net Phone: (262) 8331571

Related Public Records

Same Entity

QMD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010958377	Biometrix sro	Samorin Bratislavsky, SK
3016099072	Shomrat Molds Ltd	Hatzor Haglilit Northern, IL
8030115	BIOMETRIX LTD.	JERUSALEM, IL
8030107	DEGANIA SILICONE, LTD.	DEGANIA BET Northern, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Similar Registrations

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9616088	Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, MX
1643817	ISOMEDIX OPERATIONS INC	EL PASO, TX, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005483737. Last updated year: 2026. Please use registration number 3005483737 when referencing this establishment in official correspondence.