Identity
- Trade Name
- WCS® EUDAMEDDARCO® WCS™ FDA UDI
- Generic Name
- Orthotic shoe, non-customized FDA UDI
- Device Name
- M Black Left FDA UDI
- Model / Reference
- WCS2B/L EUDAMEDFDA UDI
- Description
- M Black Left FDA UDI
Identifiers
- Catalog Number
- WCS2B/L FDA UDI
- Primary DI / UDI-DI
- 00609271258266 EUDAMEDFDA UDI
- Basic UDI-DI
- 0609271258267J EUDAMED
- FDA Product Code
- KNP FDA UDI
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
- GMDN Term
- Orthotic shoe, non-customized FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthotic shoe, non-customized
Darco® Wcs™ by Darco (Europe) GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthotic shoe, non-customized.
- DARCO® GentleStep™ Shoe — DARCO International, Inc. · Class I
- VIVE — VIVE HEALTH LLC · Class I
- POGO™ Pulsus — DARCO International, Inc. · Class I
- POGO™ Pulsus — DARCO International, Inc. · Class I
- Position Health® Classic Post-Op Shoe — Walgreen Health Solutions, LLC · Class I
- DARCO® GentleStep™ Shoe — DARCO International, Inc. · Class I
- DARCO® GentleStep™ Shoe — DARCO International, Inc. · Class I
- DARCO® Duo™ Medical-surgical shoe — DARCO International, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Darco (Europe) GmbH
Sources (2)
- FDA UDI 104424d2-93b8-4903-a908-5fcfe26ed5d6 34 fields · synced Oct 7, 2026
- EUDAMED ab7a239e-2b4a-48a9-94d5-bc9fcbce0b7c 61 fields · synced Oct 7, 2026