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Hollister

by Hollister Incorporated 117 variants

Ref 7600144

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number610075D03P092S0368DA Basic UDI-DIDate12 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00610075092697 UDI-DIDate30 Sep 2022ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Hollister EUDAMED
VaPro GUDID
Generic Name
Single-administration urethral drainage catheter
Model / Ref / Catalog
7600144
Primary DI / UDI-DI
00610075092697, 00610075061266
Basic UDI-DI
610075D03P092S0368DA, 610075D03P081S0258C4
Unit of Use DI
20610075092691, 00610075080618
510(k) Number
FDA Product Code
GBM
EMDN Code
U01010501 Nelaton catheters, self-lubricating
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5130
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 14 French
Length — 16 Inch
Length — 40 Centimeter

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
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (18)

  • 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