Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008191244

FEI Number

3008191244

Entity Name

Hollister Medical India Private Limited

City/State/Country

Bawal, Rewari Haryana, IN

Establishment Address

Plot No. 27, Sector 5, Phase II, HSIIDC Growth Center, Bawal, Rewari Haryana 123501, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hollister Inc. (Owner Number: 1480288)

Owner / Operator Contact Address

2000 HOLLISTER DR., --, Libertyville, IL 60048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Apogee Plus InstantCath Protect Apogee Catheter Insertion Kit VaPro Pocket Plus Kit InstantCath Urinary Leg Bag BEDSIDE URINE COLLECTOR Hollister Vented Leg Bag Apogee IC New Image Hollister Advance Advance Plus Pocket Advance Plus Urinary Night Drainage Bags

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2004-06-28
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2010-02-06
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2004-06-28
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	1995-04-19
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2004-06-28
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	1992-07-21
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-11-13
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2007-11-13
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-09-27

Official Correspondent

Sofia Abreu Read

US Agent Details

Sofia Abreu-Read Business: Hollister Inc. Email: regulatoryaffairs@Hollister.com Phone: (847) 9321798

Related Public Records

Same Entity

Hollister Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016675012	Hollister Lietuva UAB	Kaunas district, LT
9616668	HOLLISTER ULC	REHINS BALLINA Mayo, IE
1119193	HOLLISTER INCORPORATED	STUARTS DRAFT, VA, US
2320961	HOLLISTER, INC.	Mount Juliet, TN, US
3014404707	Hollister Services BV	Roosendaal Noord-Brabant, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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

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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3009504230	Sterigenics Radiation Technologies IN, Inc	Columbia City, IN, US
3007829657	ROBLING MEDICAL, LLC	Youngsville, NC, US
3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008191244. Last updated year: 2026. Please use registration number 3008191244 when referencing this establishment in official correspondence.