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Athena Thigh Support
EUDAMEDClass I (EU MDR)
Ref 512001(XL/UNI/Blue)Model Athena Thigh Support
Identity
- Trade Name
- Athena Thigh Support EUDAMED
- Model / Reference
- Athena Thigh Support EUDAMED512001(XL/UNI/Blue) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964463603 EUDAMED
- Basic UDI-DI
- 47199644651WF EUDAMED
- EMDN Code
- Y061217 THIGH ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Athena Thigh Support by Orthotech Rehabilitation Co., Ltd. — 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 | 47199644651WF | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 63c372fb-c7bb-49b6-9b71-df69de74b0c6 61 fields · synced Oct 5, 2026