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Wrist Wrap
EUDAMEDClass I (EU MDR)
Ref 1083-BG-F-1Ref 2181-BG-F-1Ref RH101-BK-F-1Ref 1081-BG-F-1Ref 2081-BG-F-1Ref 1081-BK-F-1
Identity
- Trade Name
- Wrist Wrap EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 1083-BG-F-1 EUDAMED2181-BG-F-1 EUDAMEDRH101-BK-F-1 EUDAMED1081-BG-F-1 EUDAMED2081-BG-F-1 EUDAMED1081-BK-F-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863690698 EUDAMED04719863692494 EUDAMED04713375500513 EUDAMED04719863690681 EUDAMED04719863692500 EUDAMED04711769140604 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
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 Wrap 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 (6)
- EUDAMED 69ac5f0c-f647-4986-9d4a-a6d98597570f 61 fields · synced Aug 2, 2026
- EUDAMED 5d5dbce6-0271-4961-ac42-156005e2ff3e 61 fields · synced May 17, 2026
- EUDAMED ea230912-5c73-4718-9ccc-cf18932ba7fd 61 fields · synced May 17, 2026
- EUDAMED a6978d7d-d6a3-4143-b3a7-4325553cef27 61 fields · synced May 18, 2026
- EUDAMED 9f19ac4c-eb02-47f5-b95f-f7281b0147be 61 fields · synced May 18, 2026
- EUDAMED 8b9f21d0-d5da-4ed2-96e1-97a770797441 61 fields · synced May 18, 2026