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Ankle Protector
EUDAMEDClass I (EU MDR)
Ref 2902-GY-L-1Ref 2902-GY-XL-1Ref 2902-GY-M-1
Identity
- Trade Name
- Ankle Protector EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 2902-GY-L-1 EUDAMED2902-GY-XL-1 EUDAMED2902-GY-M-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769153413 EUDAMED04711769153420 EUDAMED04711769153406 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
Ankle Protector 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 (3)
- EUDAMED 85ee931e-81da-4db0-b8b6-347d12079f29 61 fields · synced Jul 13, 2026
- EUDAMED f1ed8a80-8e1f-4843-97e4-25e0fa53717c 61 fields · synced May 17, 2026
- EUDAMED a63182be-4f5b-4699-8e22-4c363cc87aef 61 fields · synced May 18, 2026