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Wrist Stabilizer
EUDAMEDClass I (EU MDR)
Ref 2984-R-GY-M-1Ref 2984-L-GY-XXXXL-1Ref 2984-R-GY-XXXL-1Ref 2984-R-GY-XL-1Ref 2984-L-GY-XL-1Ref 2984-R-GY-L-1Ref 2984-L-GY-XXXL-1
Identity
- Trade Name
- Wrist Stabilizer EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 2984-R-GY-M-1 EUDAMED2984-L-GY-XXXXL-1 EUDAMED2984-R-GY-XXXL-1 EUDAMED2984-R-GY-XL-1 EUDAMED2984-L-GY-XL-1 EUDAMED2984-R-GY-L-1 EUDAMED2984-L-GY-XXXL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769152577 EUDAMED04711769143865 EUDAMED04711769157275 EUDAMED04711769152591 EUDAMED04711769157312 EUDAMED04711769152584 EUDAMED04711769157268 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
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 Stabilizer 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 (7)
- EUDAMED c1f75e81-cabe-481f-8ae6-70112e375d72 61 fields · synced Oct 6, 2026
- EUDAMED f32bc6db-8531-4b32-a1d2-febbc3bb4e25 61 fields · synced May 17, 2026
- EUDAMED 0ab179ab-65cb-49f6-aa79-117ef9df6d52 61 fields · synced May 17, 2026
- EUDAMED b7351948-d3ea-40c5-8e10-ebd4939f1f26 61 fields · synced May 17, 2026
- EUDAMED 7ad75632-fedb-4de8-9ff1-96daa2fabcaa 61 fields · synced May 18, 2026
- EUDAMED 86c36b1a-67de-4ddd-98c9-bcf6638bd9aa 61 fields · synced May 18, 2026
- EUDAMED d85a370a-9fd5-44f2-920a-1f4631d7e253 61 fields · synced May 18, 2026