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Athena Thigh Support
EUDAMEDClass I (EU MDR)
Ref 512001(M/UNI/Blue)Model Athena Thigh Support:512001Ref 512001(L/UNI/Blue)
Identity
- Trade Name
- Athena Thigh Support EUDAMED
- Device Name
- Knee Brace (Thigh Support) EUDAMED
- Model / Reference
- Athena Thigh Support:512001 EUDAMED512001(M/UNI/Blue) EUDAMED512001(L/UNI/Blue) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872869146 EUDAMED04719872869160 EUDAMED
- Basic UDI-DI
- 47198728651WH 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
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
Athena Thigh Support by Zhangpu Ortholife 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 | 47198728651WH | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ad5679f8-1911-4281-8d67-75532e2e634d 61 fields · synced Oct 6, 2026
- EUDAMED 75c54b65-1673-4200-8ec4-94470e52180c 61 fields · synced May 19, 2026