Orthopedic Splint
by Hebei Youqi Medical Instrument Ltd. 17 variants
Model 5cm*25cm 7.5cm*30cm 7.5cm*75cm 7.5cm*90cm 10cm*40cm 10cm*45cm 10cm*50cm 10cm*65cm 10cm*75cm 12.5cm*50cm 12.5cm*65cm 12.5cm*75cm 12.5cm*90cm 12.5cm*115cm 12.5cm*120cm 15cm*75cm 15cm*115cm
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697613843OS01NR 06976138431051 | Date18 Jul 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Orthopedic Splint
- Model / Reference
- 5cm*25cm 7.5cm*30cm 7.5cm*75cm 7.5cm*90cm 10cm*40cm 10cm*45cm 10cm*50cm 10cm*65cm 10cm*75cm 12.5cm*50cm 12.5cm*65cm 12.5cm*75cm 12.5cm*90cm 12.5cm*115cm 12.5cm*120cm 15cm*75cm 15cm*115cm
- Primary DI / UDI-DI
- 06976138431051
- Basic UDI-DI
- 697613843OS01NR
- EMDN Code
- M03050202 Synthetic cast bandages and splints
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000033746
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hebei Youqi Medical Instrument Ltd.
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