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Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 410005(XS/Right/Gray&Silver)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 etcRef 410005(M/Left/Gray&Silver)Ref 410004(S/Right/Gray&Silver)Ref 410004(XL/Right/Gray&Silver)Ref 410005(XL/Right/Gray&Silver)Ref 410007(M/Right/Gray&Silver)Ref 410004(L/Right/Gray&Silver)Ref 410005(L/Right/Gray&Silver)Ref 410004(S/Left/Gray&Silver)Ref 410007(M/Left/Gray&Silver)Ref 410005(S/Right/Gray&Silver)Ref 410004(M/Left/Gray&Silver)Ref 410007(S/Left/Gray&Silver)Ref 410007(S/Right/Gray&Silver)Ref 410005(XL/Left/Gray&Silver)
Identity
- Trade Name
- Wrist Brace EUDAMED
- Device Name
- Wrist Splint (Wrist orthosis) EUDAMED
- 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 EUDAMED410005(XS/Right/Gray&Silver) EUDAMED410005(M/Left/Gray&Silver) EUDAMED410004(S/Right/Gray&Silver) EUDAMED410004(XL/Right/Gray&Silver) EUDAMED410005(XL/Right/Gray&Silver) EUDAMED410007(M/Right/Gray&Silver) EUDAMED410004(L/Right/Gray&Silver) EUDAMED410005(L/Right/Gray&Silver) EUDAMED410004(S/Left/Gray&Silver) EUDAMED410007(M/Left/Gray&Silver) EUDAMED410005(S/Right/Gray&Silver) EUDAMED410004(M/Left/Gray&Silver) EUDAMED410007(S/Left/Gray&Silver) EUDAMED410007(S/Right/Gray&Silver) EUDAMED410005(XL/Left/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892933148 EUDAMED04719892933483 EUDAMED04719872862833 EUDAMED04719872862857 EUDAMED04719892931380 EUDAMED04719872863052 EUDAMED04719872862796 EUDAMED04719892933513 EUDAMED04719872862826 EUDAMED04719872863045 EUDAMED04719872862918 EUDAMED04719872862888 EUDAMED04719872863069 EUDAMED04719872863076 EUDAMED04719872862925 EUDAMED
- Basic UDI-DI
- 47198728641WE EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wrist Brace by Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 47198728641WE | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (15)
- EUDAMED 1963e5bb-371e-421f-b5be-eb6139d8c814 61 fields · synced Oct 6, 2026
- EUDAMED e43ae6ea-07b9-4c3c-94cf-993354654ce4 61 fields · synced May 16, 2026
- EUDAMED 7873e674-36ff-4041-8ff2-1bc6089f1c4d 61 fields · synced May 16, 2026
- EUDAMED b36044b4-89d2-429a-a32a-30511a5dc470 61 fields · synced May 16, 2026
- EUDAMED f011ae1f-7902-4cca-8402-53411a12bd46 61 fields · synced May 17, 2026
- EUDAMED 29eb37a3-6648-4327-8176-21a817664796 61 fields · synced May 17, 2026
- EUDAMED e2f6507f-cdd8-4291-af51-4ab8f9225014 61 fields · synced May 18, 2026
- EUDAMED f2059545-a240-483c-ab75-0e5860b70ce2 61 fields · synced May 18, 2026
- EUDAMED 2b255145-537c-4785-a2c8-0430cd8a6b6c 61 fields · synced May 18, 2026
- EUDAMED 89dc5181-4ba5-46ae-8b37-bda8667c00da 61 fields · synced May 18, 2026
- EUDAMED 29cb741c-b36b-4560-9cf4-6f6d22fd3a4e 61 fields · synced May 18, 2026
- EUDAMED 2452bbe5-1033-4034-b09a-5e684c1c8434 61 fields · synced May 18, 2026
- EUDAMED 6b196923-f809-4d5b-b936-7a153cb7979e 61 fields · synced May 19, 2026
- EUDAMED e98998fb-efa6-4386-af66-81242eb187e7 61 fields · synced May 19, 2026
- EUDAMED aa37c6fb-7bef-4d63-b6f1-652c152ea3a3 61 fields · synced May 19, 2026