Identity
- Device Name
- HYGIA CAST EUDAMED
- Model / Reference
- HYGIA CAST - WS-SP004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 138800211WSSP004041 EUDAMED
- Basic UDI-DI
- 88002111EUCAJH EUDAMED
- Direct Marketing DI
- 138800211WSSP004041 EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Hygia Cast by Woosam Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88002111EUCAJH | Class I | Active |
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Manufacturer
- Manufacturer
- Woosam Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000045208
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED e6c0d826-54b5-469d-b3ad-be98e077c596 61 fields · synced Jun 19, 2026