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Snug-fit Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 4380-L-BK-M-1Ref 4380-L-BK-L-1Ref 4380-L-BK-S-1
Identity
- Trade Name
- Snug-fit Wrist Brace EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 4380-L-BK-M-1 EUDAMED4380-L-BK-L-1 EUDAMED4380-L-BK-S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769154779 EUDAMED04711769154786 EUDAMED04711769154762 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
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
Snug-fit Wrist 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 f018214c-e357-4899-9161-0b2b8394b6a3 61 fields · synced Jul 9, 2026
- EUDAMED 9f9ef4c9-201f-474d-95fe-efe8aac1aeef 61 fields · synced May 16, 2026
- EUDAMED 1f7631f7-be39-4b18-b990-9bca0db396da 61 fields · synced May 18, 2026