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Orthopedic Casting Splint
EUDAMEDClass I (EU MDR)
Ref 12.5*30cmModel 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 EUDAMED12.5*30cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977647081164 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
Category: Hand/finger splint, reusable
Orthopedic Casting Splint by Shanghai YouJia Medical Supply Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
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 666ce6c9-c2be-46ee-9137-89b42391356b 61 fields · synced Jun 17, 2026