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Hollister

by Hollister Incorporated EUDAMEDGUDID

Active European Union EUDAMED: not on the EU market

Ref 11216

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D03P010S027886 Basic UDI-DIDate3 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075068517 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  • Withdrawn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

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-2392-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008
    • Terminated Z-2391-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008
    • Terminated Z-2390-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008
    • Terminated Z-2393-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008
    • Terminated Z-2394-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008

    Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.

Specification

EUDAMED · GUDID

Trade Name
Hollister EUDAMED
Apogee IC GUDID
Apogee GUDID
Generic Name
Single-administration urethral drainage catheter
Device Name
Urethral Intermittent Catheter, Nelaton
Model / Reference
11216, 11216Q
Primary DI / UDI-DI
00610075068517, 00610075205219
Basic UDI-DI
610075D03P010S027886
Unit of Use DI
00610075068920
510(k) Number
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
Length — 16 Inch
Catheter Gauge — 12 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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