Back brace
by Shandong Esp Healthcare Co., Ltd.
Ref ZRWM02Model ZRWM02, ZRWM03, ZRWM06, ZRWM20, ZRWM21, ZRWM22, ZRWM23, ZRWM24, ZRWM30, ZRWM30B, ZRWM30C, ZRWM31, ZRWM35, ZRWM36, ZRWM39, ZRWM40, ZRWM41, ZRWM49
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 | Number697826271BD04KE 06978262712112 | Date11 Feb 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- Withdrawn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
- Device Name
- Back brace
- Model / Reference
- ZRWM02, ZRWM03, ZRWM06, ZRWM20, ZRWM21, ZRWM22, ZRWM23, ZRWM24, ZRWM30, ZRWM30B, ZRWM30C, ZRWM31, ZRWM35, ZRWM36, ZRWM39, ZRWM40, ZRWM41, ZRWM49
- Primary DI / UDI-DI
- 06978262712112
- Basic UDI-DI
- 697826271BD04KE
- EMDN Code
- Y090699 Devices for body protection - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000046165
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shandong Esp Healthcare 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