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Motion Control Knee Splint
EUDAMEDClass I (EU MDR)
Ref 4139-20-BU-F-1Ref 4139-18-BU-F-1Ref 4039-26-BU-F-1Ref 4039-18-BU-F-1Ref 4039-22-BU-F-1
Identity
- Trade Name
- Motion Control Knee Splint EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 4139-20-BU-F-1 EUDAMED4139-18-BU-F-1 EUDAMED4039-26-BU-F-1 EUDAMED4039-18-BU-F-1 EUDAMED4039-22-BU-F-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863694528 EUDAMED04711769144206 EUDAMED04719863694887 EUDAMED04719863694863 EUDAMED04719863694870 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
Motion Control Knee Splint 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 (5)
- EUDAMED 9a086b24-f551-4ac2-bee3-9ac2c9c3d8ff 61 fields · synced Oct 6, 2026
- EUDAMED 1ce93e60-d8e1-4c59-a8ee-7c2038279413 61 fields · synced May 17, 2026
- EUDAMED 149f89e8-8c8d-4020-8cb4-62d5ce9d3c00 61 fields · synced May 17, 2026
- EUDAMED c636b0e6-06d2-496e-93fa-40639140029a 61 fields · synced May 19, 2026
- EUDAMED 96c840c8-1170-418e-86be-4ac404f0fb6c 61 fields · synced May 19, 2026