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Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 410004(M/Right/Gray&Silver)Model Universal Wrist Brace:410001 Wrap-around Wrist Brace:410002 Wrist/ Forearm Splint:410003 Wrist Brace:410004 Wrist Brace:410005 Wrist Splint:410006 Wrist Brace:410007 Universal Wrist Splint:410008 etcRef 410005(S/Left/Gray&Silver)Ref 410007(M/Right/Gray&Silver)Ref 410004(M/Left/Gray&Silver)Ref 410007(S/Right/Gray&Silver)Ref 410005(XL/Right/Gray&Silver)Ref 410004(L/Right/Gray&Silver)Ref 410004(L/Left/Gray&Silver)Ref 410005(M/Right/Gray&Silver)Ref 410007(S/Left/Gray&Silver)Ref 410007(M/Left/Gray&Silver)
Identity
- Trade Name
- Wrist Brace EUDAMED
- Device Name
- Wrist Splint (Wrist orthosis) EUDAMED
- Model / Reference
- Universal Wrist Brace:410001 Wrap-around Wrist Brace:410002 Wrist/ Forearm Splint:410003 Wrist Brace:410004 Wrist Brace:410005 Wrist Splint:410006 Wrist Brace:410007 Universal Wrist Splint:410008 etc EUDAMED410004(M/Right/Gray&Silver) EUDAMED410005(S/Left/Gray&Silver) EUDAMED410007(M/Right/Gray&Silver) EUDAMED410004(M/Left/Gray&Silver) EUDAMED410007(S/Right/Gray&Silver) EUDAMED410005(XL/Right/Gray&Silver) EUDAMED410004(L/Right/Gray&Silver) EUDAMED410004(L/Left/Gray&Silver) EUDAMED410005(M/Right/Gray&Silver) EUDAMED410007(S/Left/Gray&Silver) EUDAMED410007(M/Left/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892937658 EUDAMED04719892937665 EUDAMED04719892937818 EUDAMED04719892937641 EUDAMED04719892937832 EUDAMED04719964465713 EUDAMED04719892937559 EUDAMED04719892937542 EUDAMED04719964467816 EUDAMED04719892937825 EUDAMED04719892937801 EUDAMED
- Basic UDI-DI
- 47199644641WC 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 Orthotech 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 | 47199644641WC | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (11)
- EUDAMED b10ee37e-84d0-48c5-ad84-b64996cd03b9 61 fields · synced Oct 6, 2026
- EUDAMED e305ef92-d2c3-4c00-a631-61150c1aefbd 61 fields · synced May 16, 2026
- EUDAMED 8c332ab6-ba7a-47bd-aa38-e22577e5cc65 61 fields · synced May 16, 2026
- EUDAMED cb678ea4-5085-427b-9615-a6e934a6f52c 61 fields · synced May 16, 2026
- EUDAMED 4642e648-43d7-47a0-ae06-2f7ea68cf87d 61 fields · synced May 17, 2026
- EUDAMED 14843c1b-309d-4e93-9cd6-59ea25a6a337 61 fields · synced May 17, 2026
- EUDAMED ea26924f-9414-41ad-810d-d5d3bf9360f1 61 fields · synced May 17, 2026
- EUDAMED d90f51ae-4ac7-4c25-9d83-30115161ca9a 61 fields · synced May 17, 2026
- EUDAMED 97267202-e199-46d8-91ef-ea08a5c78ac5 61 fields · synced May 17, 2026
- EUDAMED f2c4ed2a-f1ea-4ee3-8607-e01e1859d05e 61 fields · synced May 18, 2026
- EUDAMED d6dedeac-5275-4ca7-91e9-b3fcdda939f5 61 fields · synced May 18, 2026