Orthopedic Splint
by Beijing Jinwei Kangda Medical Instrument Ltd. EUDAMED
Active
Ref 210/5.0cm×25cmModel 210/5.0cm×25cm 312/7.5cm×30cm 313/7.5cm×33cm 314/7.5cm×35cm 315/7.5cm×38cm 320/7.5cm×50cm 322/7.5cm×55cm 335/7.5cm×90cm 412/10.0cm×30cm 415/10.0cm×40cm 417/10.0cm×43cm 418/10.0cm×45cm 420/10.0cm×50cm etc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number695708345008KZ | Date15 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Orthopedic Splint
- Model / Reference
- 210/5.0cm×25cm 312/7.5cm×30cm 313/7.5cm×33cm 314/7.5cm×35cm 315/7.5cm×38cm 320/7.5cm×50cm 322/7.5cm×55cm 335/7.5cm×90cm 412/10.0cm×30cm 415/10.0cm×40cm 417/10.0cm×43cm 418/10.0cm×45cm 420/10.0cm×50cm etc., 210/5.0cm×25cm
- Primary DI / UDI-DI
- 06957083441135
- Basic UDI-DI
- 695708345008KZ
- EMDN Code
- M03050202 Synthetic cast bandages and splints
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000011656
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No