Orthopedic Cast
by Beijing Jinwei Kangda Medical Instrument Ltd. EUDAMED
Active
Ref 2in/5.0cm×200cmModel 2in/5.0cm×200cm 5.0cm×280cm 5.0cm×360cm 3in/7.5cm×200cm 7.5cm×280cm 7.5cm×360cm 4in/10.0cm×200cm 10.0cm×280cm 10.0cm×360cm 5in/12.5cm×200cm 12.5cm×280cm 12.5cm×360cm 6in/15.0cm×200cm 15.0cm×280cm etc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number695708345007KX | 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- Withdrawn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 Cast
- Model / Reference
- 2in/5.0cm×200cm 5.0cm×280cm 5.0cm×360cm 3in/7.5cm×200cm 7.5cm×280cm 7.5cm×360cm 4in/10.0cm×200cm 10.0cm×280cm 10.0cm×360cm 5in/12.5cm×200cm 12.5cm×280cm 12.5cm×360cm 6in/15.0cm×200cm 15.0cm×280cm etc., 2in/5.0cm×200cm
- Primary DI / UDI-DI
- 06957083440015
- Basic UDI-DI
- 695708345007KX
- 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