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Light Knee Stabilizer
EUDAMEDClass I (EU MDR)
Ref 2034-BG-MRef 2034-BG-LRef 2034-BG-XL
Identity
- Trade Name
- Light Knee Stabilizer EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 2034-BG-M EUDAMED2034-BG-L EUDAMED2034-BG-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840270602203 EUDAMED00840270602210 EUDAMED00840270602227 EUDAMED
- Basic UDI-DI
- 08402706CL1024M EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Light Knee Stabilizer by OPPO Medical Inc. — 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 | 08402706CL1024M | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Inc.
- EUDAMED SRN
- US-MF-000005202
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED aeec7d51-5c01-41ad-8dba-2bc283e7f8ec 61 fields · synced Oct 6, 2026
- EUDAMED 6180e7b2-2527-473c-bd7f-9724acacd5c2 61 fields · synced May 19, 2026
- EUDAMED d61970fb-36ba-4e9d-a01a-a8157e032748 61 fields · synced May 19, 2026