Identity
- Device Name
- THERMOPLASTIC SPLINT EUDAMED
- Model / Reference
- POCKET YOGIPS - USA800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 138800211USA800025 EUDAMED
- Basic UDI-DI
- 88002111EUTHLJ EUDAMED
- Direct Marketing DI
- 138800211USA800025 EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Thermoplastic 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 | 88002111EUTHLJ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Woosam Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000045208
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 5b37b222-b5ef-4843-aa8b-55089f02e054 61 fields · synced Jun 18, 2026