Identity
- Device Name
- Thumb Spica Splint EUDAMED
- Model / Reference
- Thumb Spica Splint (Universal) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906176122350 EUDAMED
- Basic UDI-DI
- 890617612M403DA EUDAMED
- Direct Marketing DI
- 08906176122350 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Thumb Spica Splint by Medequip Healthcare Solutions Pvt 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 | 890617612M403DA | Class I | Active |
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Manufacturer
- Manufacturer
- Medequip Healthcare Solutions Pvt Ltd
- EUDAMED SRN
- IN-MF-000039598
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 30fe8b6a-a96b-4631-b6b1-3f9551dfe27c 61 fields · synced Jun 18, 2026