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Knee Immobilizer
EUDAMEDClass I (EU MDR)
Ref 4030-20-BG-S-1Ref 4030-23-BG-S-1Ref 4030-23-BG-L-1Ref 4030-20-BG-M-1Ref 4030-23-BG-M-1Ref 4030-20-BG-XL-1Ref 4030-20-BG-L-1Ref 4030-23-BG-XL-1
Identity
- Trade Name
- Knee Immobilizer EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 4030-20-BG-S-1 EUDAMED4030-23-BG-S-1 EUDAMED4030-23-BG-L-1 EUDAMED4030-20-BG-M-1 EUDAMED4030-23-BG-M-1 EUDAMED4030-20-BG-XL-1 EUDAMED4030-20-BG-L-1 EUDAMED4030-23-BG-XL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863692807 EUDAMED04719863692845 EUDAMED04719863692869 EUDAMED04719863692814 EUDAMED04719863692852 EUDAMED04719863692838 EUDAMED04719863692821 EUDAMED04719863692876 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
Knee Immobilizer 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 (8)
- EUDAMED 1fca21d4-28c2-453c-b3fb-2f650086bb67 61 fields · synced Jul 26, 2026
- EUDAMED 910ff4db-4e2e-4993-aedf-b84541684c16 61 fields · synced May 11, 2026
- EUDAMED ee9bd5fe-f60a-4b2c-89c6-be1599166cf5 61 fields · synced May 17, 2026
- EUDAMED 3cd65683-a066-4473-88ae-255ea66808ab 61 fields · synced May 17, 2026
- EUDAMED 9795121d-89b5-4b82-bf6a-4e7cc2a1e797 61 fields · synced May 17, 2026
- EUDAMED c2977b7c-89e5-452a-9abc-3a4b887aaa01 61 fields · synced May 19, 2026
- EUDAMED 9d11f8b1-a308-4783-a0c4-4dc20bc80d03 61 fields · synced May 19, 2026
- EUDAMED 214c1f1b-f1e7-4590-8b51-646374b5e3c4 61 fields · synced May 19, 2026