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Knee Stabilizer
EUDAMEDClass I (EU MDR)
Ref 2320-GY-M-1Ref 2320-GY-XXL-1Ref 1030-BG-S-1Ref 2133-BG-M-1Ref 2320-GY-L-1Ref 2133-BG-S-1Ref 1030-BG-XL-1Ref 2320-GY-S-1
Identity
- Trade Name
- Knee Stabilizer EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 2320-GY-M-1 EUDAMED2320-GY-XXL-1 EUDAMED1030-BG-S-1 EUDAMED2133-BG-M-1 EUDAMED2320-GY-L-1 EUDAMED2133-BG-S-1 EUDAMED1030-BG-XL-1 EUDAMED2320-GY-S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769144015 EUDAMED04711769144046 EUDAMED04719863690339 EUDAMED04719863695815 EUDAMED04711769144022 EUDAMED04719863695808 EUDAMED04719863690360 EUDAMED04711769144008 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
EUDAMEDEUDAMED
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 Stabilizer 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 cb915dae-d537-4c56-b5f7-678319df3adc 61 fields · synced Jul 21, 2026
- EUDAMED 83c11b4a-1e0b-4247-be1e-4fc015c763b1 61 fields · synced May 16, 2026
- EUDAMED bd3a4f99-4828-46c3-afb1-a12ec0e35d8d 61 fields · synced May 18, 2026
- EUDAMED 80d811c7-4d9a-40a6-a3c8-13eceda50757 61 fields · synced May 18, 2026
- EUDAMED 8318430f-af18-477e-ab70-527796633f6a 61 fields · synced May 18, 2026
- EUDAMED dce49bc3-e819-4481-a96b-8a9dc18d6afc 61 fields · synced May 18, 2026
- EUDAMED b9074e14-2f49-4b97-8995-b30f6fcf892f 61 fields · synced May 18, 2026
- EUDAMED ae582a7d-97d2-4bad-9760-af14c78d7017 61 fields · synced May 18, 2026