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Waterproof Cast Cover PVC

by Fbgc Limited

Ref MG-LEG-CCS01-LGModel Waterproof Cast Cover PVC

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, self-declared

Class I: no certifier involved

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
United StatesGUDID listing GUDID Number05060551222738 UDI-DI Date11 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number9529854WCCPVC01M3 Basic UDI-DI 05060551222738UDI-DIDate26 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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

Generic Name
Cast/bandage waterproof bathing cover, reusable
Model / Reference
Waterproof Cast Cover PVC, MG-LEG-CCS01-LG
Primary DI / UDI-DI
05060551222738
Basic UDI-DI
9529854WCCPVC01M3
FDA Product Code
KIA
EMDN Code
M030599 Immobilisation systems and devices - other
GMDN Term
Cast/bandage waterproof bathing cover, reusable
Device Class
Class I
Regulation Number
880.6185
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
UK-MF-000046785
Authorised representative
AF Pharma Service Europe SL ES-AR-000018076

Other devices from Fbgc Limited

See all devices from Fbgc Limited →

Properties

  • Single Use
  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • 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
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No