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Contour Knee Support
EUDAMEDClass I (EU MDR)
Ref 1132-BK-L-1Ref 1132-BK-M-1Ref 1132-BK-XXL-1Ref 1132-BK-XL-1Ref 1132-BK-S-1Ref 1132-BK-XXXL-1
Identity
- Trade Name
- Contour Knee Support EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 1132-BK-L-1 EUDAMED1132-BK-M-1 EUDAMED1132-BK-XXL-1 EUDAMED1132-BK-XL-1 EUDAMED1132-BK-S-1 EUDAMED1132-BK-XXXL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769144879 EUDAMED04711769144862 EUDAMED04711769143988 EUDAMED04711769144886 EUDAMED04711769144855 EUDAMED04711769143995 EUDAMED
- Basic UDI-DI
- 471986369CL102DF EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - 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
Contour Knee 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 | 471986369CL102DF | 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 82a58111-e967-417d-bc3b-e9901a9811e9 61 fields · synced Jul 23, 2026
- EUDAMED 6c5da3af-cd0a-43da-a7ed-39d3ed252006 61 fields · synced May 17, 2026
- EUDAMED afa12ea2-f682-413d-99dd-62aad19f5c24 61 fields · synced May 18, 2026
- EUDAMED e3f020a0-0bce-419d-a671-111c170394ea 61 fields · synced May 18, 2026
- EUDAMED 7174f713-c321-4572-aa32-aaf5e596c6b5 61 fields · synced May 18, 2026
- EUDAMED b4c93398-f0f2-4d9e-aacf-c088cbb631a9 61 fields · synced May 18, 2026