Back Brace
by Cofoe Medical Technology Co., Ltd. 7 variants
Ref AP1/L码Model AP1, U9, BQ1, NL1, NE1, K2, S1, BE1, BU9, B3, B4, B5, B6, B7, C1, C2, C3, C4, C5
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 | Number69507155BBD8 06950715507087 | Date22 May 2025 | 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- Withdrawn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
- Model / Reference
- AP1, U9, BQ1, NL1, NE1, K2, S1, BE1, BU9, B3, B4, B5, B6, B7, C1, C2, C3, C4, C5, AP1/L码
- Primary DI / UDI-DI
- 06950715507087
- Basic UDI-DI
- 69507155BBD8
- EMDN Code
- Y060699 Orthoses, upper extremity - other
- Device Class
- Class I
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000001077
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Cofoe Medical Technology 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