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Hollister

by Hollister Incorporated EUDAMEDGUDID

Active European Union and United States

Ref 6074-HR, 11206, 34829

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D01P087S0135C7 Basic UDI-DIDate5 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075082773 UDI-DIDate11 Aug 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

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 GUDID
Apogee IC GUDID
Generic Name
Single-administration urethral drainage catheter
Device Name
Ileostomy Kit - 2-Piece System, 55mm Ring & 1-Piece Pouch
Urethral Intermittent Catheter, Nelaton
2-Piece Ostomy Skin Barrier, Flextend
Model / Reference
6074-HR, 11206, 34829, 11206Q
Primary DI / UDI-DI
00610075082773, 00610075068593, 00610075206612, 00610075205202
Basic UDI-DI
610075D01P087S0135C7, 610075D03P010S027886, 610075D01P064S0083A4
Unit of Use DI
00610075068913, 30610075206613
510(k) Number
FDA Product Code
GBM
EMDN Code
A1099, U01010502, A1002010401
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5130
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution
Size
Catheter Gauge — 12 French
Length — 6 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
No
Yes
GUDID
Yes

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

Show properties
  • Sterile NoEUDAMEDYesEUDAMEDGUDID
  • 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