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Orthopedic Casting Splint
EUDAMEDClass I (EU MDR)
Ref 7.5*75cmModel 5*10cm, 5*25cm, 7.5*20cm, 7.5*30cm, 7.5*55cm, 7.5*60cm, 7.5*75cm, 7.5*90cm, 10*25cm, 10*30cm, 10*40cm, 10*50cm, 10*60cm, 10*75cm, 10*90cm, 12.5*30cm, 12.5*50cm, 12.5*55cm, 12.5*60cm, 12.5*75cm, 12.5*90cm, 12.5*100cm, 12.5*115cm, etc
Identity
- Trade Name
- Orthopedic Casting Splint EUDAMED
- Device Name
- Orthopedic Casting Splint EUDAMED
- Model / Reference
- 5*10cm, 5*25cm, 7.5*20cm, 7.5*30cm, 7.5*55cm, 7.5*60cm, 7.5*75cm, 7.5*90cm, 10*25cm, 10*30cm, 10*40cm, 10*50cm, 10*60cm, 10*75cm, 10*90cm, 12.5*30cm, 12.5*50cm, 12.5*55cm, 12.5*60cm, 12.5*75cm, 12.5*90cm, 12.5*100cm, 12.5*115cm, etc EUDAMED7.5*75cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977647081072 EUDAMED
- Basic UDI-DI
- 697764708OCS001SE 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
Orthopedic Casting Splint by Shanghai YouJia Medical Supply 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 | 697764708OCS001SE | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai YouJia Medical Supply Co., Ltd.
- EUDAMED SRN
- CN-MF-000042783
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED bd8965eb-299b-4c29-bfa3-e63f2c00780e 61 fields · synced Jun 18, 2026