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Athena Knee Support Lite
EUDAMEDClass I (EU MDR)
Ref 522004(L/UNI/Blue)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 522004(S/UNI/Blue)Ref 522004(M/UNI/Blue)
Identity
- Trade Name
- Athena Knee Support Lite EUDAMED
- Device Name
- Functional Knee Brace, Knee Brace, OA Knee Brace, Post-OP Brace (Knee support orthosis) EUDAMED
- Model / Reference
- Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002 EUDAMED522004(L/UNI/Blue) EUDAMED522004(S/UNI/Blue) EUDAMED522004(M/UNI/Blue) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964464617 EUDAMED04719964464594 EUDAMED04719964464600 EUDAMED
- Basic UDI-DI
- 47199644652WH EUDAMED
- EMDN Code
- Y061209 KNEE 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 Knee Support Lite 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 | 47199644652WH | 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 (3)
- EUDAMED 5f41fbb6-eadb-4bc0-a52e-eaa9ca215fb4 61 fields · synced Oct 6, 2026
- EUDAMED 836eb25e-d931-4470-a41f-3b65b51992ec 61 fields · synced May 17, 2026
- EUDAMED e4cf51dd-35c2-4769-bd14-caf80da1eed5 61 fields · synced May 19, 2026