Splint
by Wuxi Golden Hour Medical Technology Co., Ltd 3 variants
Ref BRFS-K9M, BRFS-L, BRFS-M, BRFS-K9SModel BRFS or customized
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 | Number697719457BRFSTW | Date14 Jul 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- Withdrawn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
- Splint
- Model / Reference
- BRFS or customized, BRFS-K9M, BRFS-L, BRFS-M, BRFS-K9S
- Primary DI / UDI-DI
- 06977194570265, 06977194570203, 06977194570289, 06977194570258
- Basic UDI-DI
- 697719457BRFSTW
- EMDN Code
- M030505 Zimmer splints
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000040031
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wuxi Golden Hour Medical Technology Co., Ltd
See all devices from Wuxi Golden Hour 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