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Athena Calf Support
EUDAMEDClass I (EU MDR)
Ref 612001(M/UNI/Blue)Model Plantar Fasciitis Compression Sock:610002 Diabetic Antibacterial Socks:610003 Diabetic Daily Socks:610004Ref 612001(L/UNI/Blue)Ref 610002(M/UNI/Black)Ref 612001(XL/UNI/Blue)
Identity
- Trade Name
- Athena Calf Support EUDAMEDPlantar Fasciitis Compression Sock EUDAMED
- Device Name
- Ankle Brace, Knee Brace (Calf Support) EUDAMED
- Model / Reference
- Plantar Fasciitis Compression Sock:610002 Diabetic Antibacterial Socks:610003 Diabetic Daily Socks:610004 EUDAMED612001(M/UNI/Blue) EUDAMED612001(L/UNI/Blue) EUDAMED610002(M/UNI/Black) EUDAMED612001(XL/UNI/Blue) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964464945 EUDAMED04719964464952 EUDAMED04719964464877 EUDAMED04719964464969 EUDAMED
- Basic UDI-DI
- 47199644661WJ EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMEDY06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDNetherlands 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 Calf 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 | 47199644661WJ | 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 (4)
- EUDAMED 9a5ddaf6-f59c-450f-832f-31c0bd886388 61 fields · synced Oct 6, 2026
- EUDAMED fabec080-fbcf-4521-a21a-205554179220 61 fields · synced May 18, 2026
- EUDAMED c84e1de3-f038-4cf0-83aa-27b5823f53f0 61 fields · synced May 19, 2026
- EUDAMED 74c0e950-1997-4e8a-8f45-45ed1a65d32e 61 fields · synced May 19, 2026