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Hinged Elbow Support
EUDAMEDClass I (EU MDR)
Ref 1287-R-BG-XL-1Ref 1287-R-BG-S-1Ref 1187-BG-L-1Ref 1287-L-BG-S-1Ref 1187-BG-XL-1
Identity
- Trade Name
- Hinged Elbow Support EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 1287-R-BG-XL-1 EUDAMED1287-R-BG-S-1 EUDAMED1187-BG-L-1 EUDAMED1287-L-BG-S-1 EUDAMED1187-BG-XL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769145470 EUDAMED04711769145449 EUDAMED04719863695235 EUDAMED04711769145487 EUDAMED04719863695242 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
Hinged Elbow 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 (5)
- EUDAMED 41156610-53b5-4d1c-b55d-e4c1eb81474d 61 fields · synced Oct 6, 2026
- EUDAMED 52512753-1590-493c-b6de-eb52d6d37721 61 fields · synced May 16, 2026
- EUDAMED bcfde921-e088-440e-b2fa-df5f7dbdcf3a 61 fields · synced May 16, 2026
- EUDAMED 2fb28428-e597-4f61-92af-038685fb58cf 61 fields · synced May 17, 2026
- EUDAMED f82972e2-489b-4b01-9277-0e612c3cb23c 61 fields · synced May 18, 2026