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Finger Splints
EUDAMEDClass I (EU MDR)
Ref FS010Model FSO01, FSO02, FSO03,FSO04,FSO05,FSO06, FSO07, FSO08, FSO09,FS010,FS011
Identity
- Device Name
- Finger Splints EUDAMED
- Model / Reference
- FSO01, FSO02, FSO03,FSO04,FSO05,FSO06, FSO07, FSO08, FSO09,FS010,FS011 EUDAMEDFS010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200102162 EUDAMED
- Basic UDI-DI
- 697620010FS00178 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER 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
Finger Splints by Xiamen Ortocare Sports Health 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 | 697620010FS00178 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Ortocare Sports Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000034229
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED b241e2e2-1a36-4726-b24c-9530563a3742 61 fields · synced Jun 18, 2026