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Hollister

by Hollister Incorporated EUDAMEDGUDID

Active European Union EUDAMED: not on the EU market

Ref 11406

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D03P010S027886 Basic UDI-DIDate3 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075068623 UDI-DIDate21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Hollister EUDAMED
Apogee IC GUDID
Generic Name
Single-administration urethral drainage catheter
Device Name
Urethral Intermittent Catheter, Nelaton
Model / Reference
11406
Primary DI / UDI-DI
00610075068623 EUDAMED
00610075205233 GUDID
Basic UDI-DI
610075D03P010S027886
Unit of Use DI
00610075068944
FDA Product Code
GBM
EMDN Code
U01010502 Nelaton catheters, non self-lubricating
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 14 French
Length — 6 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00610075068623
GUDID
00610075205233
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000027818
Authorised representative
Hollister ULC IE-AR-000022119

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No