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Wrist Support
EUDAMEDClass I (EU MDR)
Ref 2281-BG-L-1Ref 4288-BG-L-1Ref 4288-BG-S-1Ref 4288-BK-M-1Ref 2980-GY-XL-1Ref 2583-BG-M-1Ref 2980-GY-XXL-1Ref 4288-BG-M-1Ref 4288-BK-L-1Ref 2980-GY-XXXL-1Ref 4288-BK-XL-1
Identity
- Trade Name
- Wrist Support EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 2281-BG-L-1 EUDAMED4288-BG-L-1 EUDAMED4288-BG-S-1 EUDAMED4288-BK-M-1 EUDAMED2980-GY-XL-1 EUDAMED2583-BG-M-1 EUDAMED2980-GY-XXL-1 EUDAMED4288-BG-M-1 EUDAMED4288-BK-L-1 EUDAMED2980-GY-XXXL-1 EUDAMED4288-BK-XL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863692326 EUDAMED04711769153871 EUDAMED04711769153857 EUDAMED04719863699592 EUDAMED04711769153833 EUDAMED04719863699202 EUDAMED04711769153840 EUDAMED04711769153864 EUDAMED04719863699608 EUDAMED04711769153956 EUDAMED04719863699615 EUDAMED
- Basic UDI-DI
- 471986369CL103DH EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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 Support by OPPO Medical Corp. — 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 | 471986369CL103DH | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (11)
- EUDAMED 65d1a01a-00c5-4afa-b31e-dfc848731a8e 61 fields · synced Jul 31, 2026
- EUDAMED 8cb0e581-43e1-4805-8e85-eb03f1ae0653 61 fields · synced May 11, 2026
- EUDAMED faa37fd1-fb55-473e-8646-d5d1afecab81 61 fields · synced May 16, 2026
- EUDAMED 37ba0f2c-d000-4f3a-a5cc-e51761343cd9 61 fields · synced May 16, 2026
- EUDAMED 0b4f94c0-b270-424b-9494-75c431996eda 61 fields · synced May 16, 2026
- EUDAMED 6b9bf4cc-507a-4e94-8c14-fddd63888983 61 fields · synced May 16, 2026
- EUDAMED c96ef0fa-a60b-4329-b38c-0294abff65cc 61 fields · synced May 17, 2026
- EUDAMED d77e270c-53d7-4455-8a88-cd2776adf574 61 fields · synced May 17, 2026
- EUDAMED ad2271e6-3500-46c9-abb1-cd26f0284087 61 fields · synced May 17, 2026
- EUDAMED 5b0ed6f2-4935-47e3-b0d1-c68038a49679 61 fields · synced May 19, 2026
- EUDAMED 9be5611c-e3f6-493f-bf67-98741af4d47c 61 fields · synced May 19, 2026