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Hygia Splint & Hygia Belt Splint
EUDAMEDClass I (EU MDR)
Ref Hygia Splint - WS-1022
Identity
- Device Name
- HYGIA SPLINT & HYGIA BELT SPLINT EUDAMED
- Model / Reference
- Hygia Splint - WS-1022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 880021110221 EUDAMED
- Basic UDI-DI
- 88002111EUSPLX EUDAMED
- Direct Marketing DI
- 880021110221 EUDAMED
- EMDN Code
- Y061219 CHEST-LUMB-SACRAL-HIP-KNEE-ANKLE-FOOT ORTHOSES 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 Splint & Hygia Belt Splint 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 | 88002111EUSPLX | 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 04ad6fda-1d63-4ba9-b9e6-bc5c5041af6b 61 fields · synced Jun 19, 2026