Head & Neck Medical External Fixation Brace
by Beijing Jinwei Kangda Medical Instrument Ltd.
Ref KDZJ-JZ-001SModel KDZJ-JZ-001 KDZJ-JZ-002 KDZJ-JZ-008 KDZJ-JZ-009 KDZJ-JZ-010 KDZJ-JZ-016 KDZJ-JZ-023 KDZJ-JZ-026 KDZJ-JZ-030 KDZJ-JZ-031
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 | Number695708345006KV 06957083422523 | 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- Withdrawn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
- Head & Neck Medical External Fixation Brace
- Model / Reference
- KDZJ-JZ-001 KDZJ-JZ-002 KDZJ-JZ-008 KDZJ-JZ-009 KDZJ-JZ-010 KDZJ-JZ-016 KDZJ-JZ-023 KDZJ-JZ-026 KDZJ-JZ-030 KDZJ-JZ-031, KDZJ-JZ-001S
- Primary DI / UDI-DI
- 06957083422523
- Basic UDI-DI
- 695708345006KV
- EMDN Code
- Y060312 Cervical spine orthoses
- 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