Splint
by Anping Jianxin Orthopedics Instrnments Co, .Ltd 2 variants
Ref JB0040/SPLINTModel JB001 JB002 JB003 JB004 JB005 JB006 JB007 JB008 JB009 JB0010 JB0011 JB0012 JB0013 JB0014 JB0031 JB0032 JB0033 JB0034 JB0035 JB0036 JB0037 JB0038 JB0039 JB0040 JB0041
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 | Number697581303SPL01NW 06975813030435 | Date16 May 2025 | 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- Withdrawn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
- Model / Reference
- JB001 JB002 JB003 JB004 JB005 JB006 JB007 JB008 JB009 JB0010 JB0011 JB0012 JB0013 JB0014 JB0031 JB0032 JB0033 JB0034 JB0035 JB0036 JB0037 JB0038 JB0039 JB0040 JB0041, JB0040/SPLINT
- Primary DI / UDI-DI
- 06975813030435
- Basic UDI-DI
- 697581303SPL01NW
- EMDN Code
- Y060603, Y061203
- Device Class
- Class I
- EU market of registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- CN-MF-000028658
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Anping Jianxin Orthopedics Instrnments Co, .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