HOLLISTER ULC

FDA Device Registration & Listing · REHINS BALLINA Mayo, IE · Registration 9616668

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616668
FEI Number
3005028195
Entity Name
HOLLISTER ULC
City/State/Country
REHINS BALLINA Mayo, IE
Establishment Address
FOXFORD RD., REHINS BALLINA Mayo F26 F3X5, IE
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

VaPro Plus Pocket (40cm/16 inch) Conform 2 Impression - C Nova NovaLife 1 Dansac New Image HOLLISTER UROSTOMY BAGS Center Point Lock Karaya 5 Securi-T USA Nova 2 NovaLife Urostomy Bags Moderma Flex NovaLife 2 GX+ NovaLife 2 Invent First Choice Tandem NovaLife 1 GX+ Compact Premier VaPro Pocket (20cm/8 inch) Onli (LCC) VaPro Pocket (40cm/16 inch) VaPro Plus Pocket (20cm/8 inch) VaPro Plus VaPro Plus Pocket VaPro Pocket VaPro Pocket VaPro Plus Pocket

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2019-10-16
EXG Bag, Urine Collecting, Ureterostomy Gastroenterology, Urology Class 1 876.5900 1992-07-21
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2015-01-14
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2022-04-12
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2018-11-27
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2016-01-22
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-05-22
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2020-01-16

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
1119193 HOLLISTER INCORPORATED STUARTS DRAFT, VA, US
2320961 HOLLISTER, INC. Mount Juliet, TN, US
3014404707 Hollister Services BV Roosendaal Noord-Brabant, NL
1480288 HOLLISTER INCORPORATED LIBERTYVILLE, IL, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616668. Last updated year: 2026. Please use registration number 9616668 when referencing this establishment in official correspondence.
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