WellFit Wrist Lacer
by Zhangpu Ortholife Rehabilitation Co., Ltd. EUDAMED
Active
Ref 410011(M/Left/Black)Model Athena Wrist Support:412003 CTS Wrist Orthosis:410009 Functional Position Splint:417001 Palm Brace:412001 Thumb Brace:412102 Thumb Brace:418003 Thumb Splint:412101 TPS THUMB BRACE:416601 TPS WRIST AND THUMB SPLINT:416602 Uni Thumb Brace:412104 etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number47198728641WE | Date15 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Wrist Splint (Wrist orthosis)
- Model / Reference
- Athena Wrist Support:412003 CTS Wrist Orthosis:410009 Functional Position Splint:417001 Palm Brace:412001 Thumb Brace:412102 Thumb Brace:418003 Thumb Splint:412101 TPS THUMB BRACE:416601 TPS WRIST AND THUMB SPLINT:416602 Uni Thumb Brace:412104 etc, 410011(M/Left/Black)
- Primary DI / UDI-DI
- 04719872869566
- Basic UDI-DI
- 47198728641WE
- EMDN Code
- Y060609 Wrist (forearm) orthoses
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000011447
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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