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Functional Position Splint
EUDAMEDClass I (EU MDR)
Ref 417001(XL/Right/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 etcRef 417001(XS/Right/Gray&Silver)Ref 417001(XL/Left/Black)Ref 417001(L/Left/Black)Ref 417001(M/Right/Black)Ref 417001(S/Left/Black)Ref 417001(S/Right/Gray&Silver)Ref 417001(S/Right/Black)Ref 417001(L/Right/Black)Ref 417001(XL/Right/Gray&Silver)
Identity
- Trade Name
- Functional Position Splint 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 EUDAMED417001(XL/Right/Black) EUDAMED417001(XS/Right/Gray&Silver) EUDAMED417001(XL/Left/Black) EUDAMED417001(L/Left/Black) EUDAMED417001(M/Right/Black) EUDAMED417001(S/Left/Black) EUDAMED417001(S/Right/Gray&Silver) EUDAMED417001(S/Right/Black) EUDAMED417001(L/Right/Black) EUDAMED417001(XL/Right/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892932905 EUDAMED04719872862697 EUDAMED04719892932912 EUDAMED04719892932288 EUDAMED04719892932257 EUDAMED04719892932899 EUDAMED04719872862673 EUDAMED04719892932882 EUDAMED04719892932264 EUDAMED04719872868514 EUDAMED
- Basic UDI-DI
- 47198728641WE EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Functional Position Splint 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 (10)
- EUDAMED 1b045fa7-ac2d-40da-a915-7a069e044a0b 61 fields · synced Oct 6, 2026
- EUDAMED 26179115-f4cb-408b-9577-1dcdc1114d87 61 fields · synced May 17, 2026
- EUDAMED 015b6e03-b5f4-40e0-8d0c-eff281176fee 61 fields · synced May 18, 2026
- EUDAMED e7bedb7c-3435-4f08-a0c3-cd366163d704 61 fields · synced May 18, 2026
- EUDAMED b095f238-443b-4e43-84f0-2044b4dfd18c 61 fields · synced May 19, 2026
- EUDAMED bd00929b-f7ce-4584-8f3f-0fb37c9acd85 61 fields · synced May 19, 2026
- EUDAMED 70c14a39-3401-4209-8fb6-506d03003bc2 61 fields · synced May 19, 2026
- EUDAMED aa007d79-c3f7-4e4a-8939-2584b0accac8 61 fields · synced May 19, 2026
- EUDAMED 5ccc23c4-86ec-4673-84c3-92ddffc68b44 61 fields · synced May 19, 2026
- EUDAMED 940ee4c5-2eb1-43f3-9aff-8bd3293c4501 61 fields · synced May 19, 2026