Lumbo-Sacral Back Brace
by Dongguan Supercare Medical Products Co., Ltd 116 variants
Ref BK-036 XLModel 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-056 BK-072 BK-073 BK-074 BK-095 BK-101 BK-103 BK-104 BK-115 BK-055 BK-015 BK-017 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 | Number697892753BackBraceLE 06978927530259 | Date13 May 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- Withdrawn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-008 BK-009 BK-011 BK-012 BK-018 BK-019 BK-026 BK-036 BK-043 BK-044 BK-047 BK-049 BK-056 BK-072 BK-073 BK-074 BK-095 BK-101 BK-103 BK-104 BK-115 BK-055 BK-015 BK-017 etc, BK-036 XL
- Primary DI / UDI-DI
- 06978927530259
- Basic UDI-DI
- 697892753BackBraceLE
- 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