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Porges Coloplast AB6218

by Coloplast A/S

Ref AB6218

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number570893263588898 Basic UDI-DI 03600040960295UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03600040960295 UDI-DI Date1 Aug 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  • Withdrawn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
X-flow EUDAMED
Porges Coloplast GUDID
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Ref / Catalog
AB6218
Primary DI / UDI-DI
03600040960295 EUDAMED
03600040143988 GUDID
Basic UDI-DI
570893263588898
FDA Product Code
EZL
EMDN Code
U010203 Urethral prostatic and bladder catheters, delinotte, with balloon
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 18 French

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
03600040960295
GUDID
03600040143988
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

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