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Palm Brace
EUDAMEDClass I (EU MDR)
Ref 2084-R-WT-L-1Ref 2084-R-WT-XL-1Ref 2084-R-WT-S-1
Identity
- Trade Name
- Palm Brace EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 2084-R-WT-L-1 EUDAMED2084-R-WT-XL-1 EUDAMED2084-R-WT-S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863692470 EUDAMED04719863696560 EUDAMED04719863692456 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
Palm Brace 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 (3)
- EUDAMED 8813fb3d-d7b5-43cf-b740-7b5e2cae647d 61 fields · synced Jul 12, 2026
- EUDAMED 666755da-e4b0-4539-8e28-052ac20d6ad4 61 fields · synced May 18, 2026
- EUDAMED b5fa1db3-0ef8-4415-bcc9-1bb9974f2f7e 61 fields · synced May 18, 2026