Spine Medical External Fixation Brace
by Beijing Jinwei Kangda Medical Instrument Ltd.
Ref KDZJ-JZ-003SModel KDZJ-JZ-003 KDZJ-JZ-004 KDZJ-JZ-005 KDZJ-JZ-006 KDZJ-JZ-007 KDZJ-JZ-011 KDZJ-JZ-012 KDZJ-JZ-015 KDZJ-JZ-017 KDZJ-JZ-018 KDZJ-JZ-019 KDZJ-JZ-020 etc.
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 | Number695708345005KT 06957083420628 | Date15 Jul 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- Withdrawn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
- Spine Medical External Fixation Brace
- Model / Reference
- KDZJ-JZ-003 KDZJ-JZ-004 KDZJ-JZ-005 KDZJ-JZ-006 KDZJ-JZ-007 KDZJ-JZ-011 KDZJ-JZ-012 KDZJ-JZ-015 KDZJ-JZ-017 KDZJ-JZ-018 KDZJ-JZ-019 KDZJ-JZ-020 etc., KDZJ-JZ-003S
- Primary DI / UDI-DI
- 06957083420628
- Basic UDI-DI
- 695708345005KT
- EMDN Code
- Y060399 Spine orthoses - other
- Device Class
- Class I
- EU 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