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Bardex® Pediatric All-Silicone Foley Catheter 165808

by C. R. Bard, Inc.

Ref 165808

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741NKZOKBON5X Basic UDI-DI 00801741029714UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741029714 UDI-DI Date31 May 2016ListedStatusListed 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  • Withdrawn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
Bardex EUDAMED
Bardex® Pediatric All-Silicone Foley Catheter GUDID
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Ref / Catalog
165808
Primary DI / UDI-DI
00801741029714
Basic UDI-DI
0801741NKZOKBON5X
FDA Product Code
KOD
EMDN Code
U010299 Urethral prostatic and bladder catheters, with balloon - other
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 8 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Other devices from C. R. Bard, Inc.

See all devices from C. R. Bard, Inc. →

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