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DARCO® Wound Care Shoe System™ WCS5B

by Darco (Europe) GmbH

Ref WCS5B

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0609271259557W Basic UDI-DI 00609271259553UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00609271259553 UDI-DI Date8 Feb 2023ListedStatusListed GUDID: not in commercial distribution

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  • Withdrawn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

Trade Name
Wound Care Shoe System™ EUDAMED
DARCO® Wound Care Shoe System™ GUDID
Generic Name
Orthotic shoe, non-customized
Model / Ref / Catalog
WCS5B
Primary DI / UDI-DI
00609271259553
Basic UDI-DI
0609271259557W
FDA Product Code
KNP
EMDN Code
Y063303 Ready-made orthotic shoes
GMDN Term
Orthotic shoe, non-customized
Device Class
Class I
Regulation Number
890.3475
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Other devices from Darco (Europe) GmbH

See all devices from Darco (Europe) GmbH →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No