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Thumb Brace
EUDAMEDClass I (EU MDR)
Ref 412102(S/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 412102(XS/Right/Gray&Silver)Ref 412102(S/Left/Gray&Silver)Ref 412102(L/Right/Gray&Silver)Ref 412102(M/Right/Gray&Silver)Ref 412102(M/Left/Black)Ref 412102(S/Left/Black)Ref 412102(L/Left/Black)Ref 412102(XS/Left/Gray&Silver)Ref 412102(L/Right/Black)
Identity
- Trade Name
- Thumb 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 EUDAMED412102(S/Right/Gray&Silver) EUDAMED412102(XS/Right/Gray&Silver) EUDAMED412102(S/Left/Gray&Silver) EUDAMED412102(L/Right/Gray&Silver) EUDAMED412102(M/Right/Gray&Silver) EUDAMED412102(M/Left/Black) EUDAMED412102(S/Left/Black) EUDAMED412102(L/Left/Black) EUDAMED412102(XS/Left/Gray&Silver) EUDAMED412102(L/Right/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892937344 EUDAMED04719964463122 EUDAMED04719892937337 EUDAMED04719892937306 EUDAMED04719892937320 EUDAMED04719964466567 EUDAMED04719964466550 EUDAMED04719964466574 EUDAMED04719964463115 EUDAMED04719964466543 EUDAMED
- Basic UDI-DI
- 47199644641WC EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Thumb 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 (10)
- EUDAMED 34d71822-48c6-4fd4-b0e6-1aed2d31889d 61 fields · synced Oct 6, 2026
- EUDAMED 737edbcb-e4ae-4cc6-87c0-ff96e6e65a64 61 fields · synced May 16, 2026
- EUDAMED 21103246-a457-4eba-adb2-9dd644929d73 61 fields · synced May 17, 2026
- EUDAMED f3346f1d-ddde-44d4-a0a9-59c872e6f8eb 61 fields · synced May 17, 2026
- EUDAMED 598a9ee4-207f-4bfa-86b7-930c1efda61f 61 fields · synced May 17, 2026
- EUDAMED 5e178b60-473a-49e8-88c2-7c110a9621f6 61 fields · synced May 17, 2026
- EUDAMED 1d9e11d6-6c7f-425f-af1a-87b8fa81a710 61 fields · synced May 17, 2026
- EUDAMED 65a3362c-2c9a-471f-884e-adba297d7074 61 fields · synced May 17, 2026
- EUDAMED 920dae96-4f65-4cef-bc53-1ca6679587fa 61 fields · synced May 18, 2026
- EUDAMED 5d5736c5-1314-4242-97a4-6a2fa9f56222 61 fields · synced May 18, 2026