Lower Limb Medical External Fixation Brace
by Beijing Jinwei Kangda Medical Instrument Ltd. 2 variants
Ref KDZJ-KB-001Model KDZJ-KB-001 KDZJ-KB-002 KDZJ-KB-003 KDZJ-KB-004 KDZJ-XB-001 KDZJ-XB-002 KDZJ-XB-003 KDZJ-XB-004 KDZJ-XB-005 KDZJ-XB-006 KDZJ-XB-007 KDZJ-XB-008 KDWZ-XB-001 KDZJ-XB-009 KDZJ-XB-010 KDZJ-XB-011 KDZJ-XB-013 KDZJ-XB-014 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 | Number695708345004KR 06957083423582 | 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- Withdrawn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
- Lower Limb Medical External Fixation Brace
- Model / Reference
- KDZJ-KB-001 KDZJ-KB-002 KDZJ-KB-003 KDZJ-KB-004 KDZJ-XB-001 KDZJ-XB-002 KDZJ-XB-003 KDZJ-XB-004 KDZJ-XB-005 KDZJ-XB-006 KDZJ-XB-007 KDZJ-XB-008 KDWZ-XB-001 KDZJ-XB-009 KDZJ-XB-010 KDZJ-XB-011 KDZJ-XB-013 KDZJ-XB-014 etc., KDZJ-KB-001
- Primary DI / UDI-DI
- 06957083423582
- Basic UDI-DI
- 695708345004KR
- EMDN Code
- Y061299 Lower extremity 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
Other devices from Beijing Jinwei Kangda Medical Instrument Ltd.
See all devices from Beijing Jinwei Kangda 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