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Porges Coloplast AA6822

by Coloplast A/S

Ref AA6822

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 Number57089326358748V Basic UDI-DI 03600040958070UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03600040958070 UDI-DI Date22 Sep 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  • Withdrawn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
Folysil EUDAMED
Porges Coloplast GUDID
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device Name
Folysil silicone catheter
Model / Ref / Catalog
AA6822
Primary DI / UDI-DI
03600040958070 EUDAMED
03600040131718 GUDID
Basic UDI-DI
57089326358748V
FDA Product Code
EZL
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
Austria
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 22 French

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
03600040958070
GUDID
03600040131718
Device ClassEUDAMED
Class IIb
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