Hollister Services BV

FDA Device Registration & Listing · Roosendaal Noord-Brabant, NL · Registration 3014404707

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
3014404707
FEI Number
3014404707
Entity Name
Hollister Services BV
City/State/Country
Roosendaal Noord-Brabant, NL
Establishment Address
Boekerrman 2, XK Oud Gastel, Roosendaal Noord-Brabant 4751, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on 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
N/A
PMA Number
N/A

All Registered Proprietary Names

VaPro Plus VaPro Plus Pocket VaPro Pocket VaPro VaPro Plus Securi-T USA TRE Dansac Hollister CeraPlus Nova 2 Premium Adapt NovaLife 1 GX+ Nova 1 HolliHesive NovaLife Invent NovaLife 2 GX+ NovaLife 2 Nova Karaya NovaLife 1 VaPro Plus Pocket (20cm/8 inch) VaPro Plus Pocket (40cm/16 inch) Infyna Chic VaPro Pocket (40cm/16 inch) VaPro Pocket (20cm/8 inch) Adapt Securi-T USA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-05-22
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2014-11-18
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2006-09-27
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2016-01-22
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2019-10-16
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2022-09-14
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2018-11-27
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2015-01-14
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2015-01-28

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
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 3014404707. Last updated year: 2026. Please use registration number 3014404707 when referencing this establishment in official correspondence.
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