Wrist Brace
by Guangdong New Design Biotechnology Co., Ltd 6 variants
Ref WX3, WY2, WX2, WY1, WB3X
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 | Number697765270WX3YL | Date22 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- Withdrawn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
- Model / Reference
- WX3, WY2, WX2, WY1, WB3X
- Primary DI / UDI-DI
- 06977652700067, 06977652700081, 06977652700050, 06977652700074, 06977652700241, 06977652700234
- Basic UDI-DI
- 697765270WX3YL, 697765270WY2YM, 697765270WX2YJ, 697765270WY1YK, 697765270WB3XT7
- EMDN Code
- Y060613 Wrist-hand-fingers orthoses
- Device Class
- Class I
- EU market of registration
- SpainAustria
Manufacturer details
- EUDAMED SRN
- CN-MF-000043910
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Guangdong New Design Biotechnology Co., Ltd
See all devices from Guangdong New Design Biotechnology 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