elbow&arm brace
by Shandong Esp Healthcare Co., Ltd.
Ref ZRWM14Model ZRWM14, ZRWM15, ZRWM32, ZRWM44, ZRWM50, ZRWM51, ZRWM52, ZRWM53, ZRWM54, ZRWM55, ZRWM56, ZRWM57, ZRWM58, ZRWM59, ZRWM60
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 | Number697826271BD06KJ 06978262712518 | Date23 Apr 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- Withdrawn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
- elbow&arm brace
- Model / Reference
- ZRWM14, ZRWM15, ZRWM32, ZRWM44, ZRWM50, ZRWM51, ZRWM52, ZRWM53, ZRWM54, ZRWM55, ZRWM56, ZRWM57, ZRWM58, ZRWM59, ZRWM60
- Primary DI / UDI-DI
- 06978262712518
- Basic UDI-DI
- 697826271BD06KJ
- EMDN Code
- Y090612 Arm and elbow protections
- 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