Lumbo-Sacral Back Brace
by Dongguan Supercare Medical Products Co., Ltd 116 variants
Ref BK-004 UModel BK-001,BK-004,BK-006,BK-008,BK-009,BK-011,BK-012,BK-018,BK-019,BK-026,BK-036,BK-043,BK-044,BK-047,BK-049,BK-052,BK-056,BK-072,BK-073,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 | Number697278239BackBraceEB 06972782390010 | Date20 Apr 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- Withdrawn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
- Lumbo-Sacral Back Brace
- Model / Reference
- BK-001, BK-004, BK-006, BK-008, BK-009, BK-011, BK-012, BK-018, BK-019, BK-026, BK-036, BK-043, BK-044, BK-047, BK-049, BK-052, BK-056, BK-072, BK-073, etc, BK-004 U
- Primary DI / UDI-DI
- 06972782390010
- Basic UDI-DI
- 697278239BackBraceEB
- EMDN Code
- Y060306 Thoracolumbar orthoses
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000028597
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Dongguan Supercare Medical Products Co., Ltd
See all devices from Dongguan Supercare Medical Products 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