CareFix
by Shanghai CareFix Medical Instrument Co., Ltd. 10 variants
Ref Straight Connecting Rod ɸ8x300mm/66408300
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 | Number69531539EFSCEF6522 06953153914400 | Date12 Jun 2026 | 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- Withdrawn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
- External Fixator System
- Model / Reference
- Straight Connecting Rod ɸ8x300mm/66408300
- Primary DI / UDI-DI
- 06953153914400
- Basic UDI-DI
- 69531539EFSCEF6522
- Direct Marketing DI
- 06953153914400
- EMDN Code
- P09120499 External bone fixation systems - other
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000056140
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Shanghai CareFix Medical Instrument Co., Ltd.
See all devices from Shanghai CareFix Medical Instrument 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