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Athena Knee Support
EUDAMEDClass I (EU MDR)
Ref 522005(L/UNI/Blue)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 522005(M/UNI/Blue)Ref 522006(S/UNI/Blue)Ref 522006(M/UNI/Blue)Ref 522006(L/UNI/Blue)Ref 522006(XL/UNI/Blue)
Identity
- Trade Name
- Athena Knee Support EUDAMEDAthena Knee Support Pro 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 EUDAMED522005(L/UNI/Blue) EUDAMED522005(M/UNI/Blue) EUDAMED522006(S/UNI/Blue) EUDAMED522006(M/UNI/Blue) EUDAMED522006(L/UNI/Blue) EUDAMED522006(XL/UNI/Blue) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964464655 EUDAMED04719964464648 EUDAMED04719964464679 EUDAMED04719964464686 EUDAMED04719964464693 EUDAMED04719964464709 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 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 (6)
- EUDAMED d198366b-ad56-42cb-ad8e-aa04a8f2aa27 61 fields · synced Oct 6, 2026
- EUDAMED 92678436-912e-4cfc-838a-b5961ceebfb6 61 fields · synced May 17, 2026
- EUDAMED bea651ce-155e-4620-bc4a-62473c491195 61 fields · synced May 17, 2026
- EUDAMED 961351bd-6db8-4cdd-aa3b-148a08e038d6 61 fields · synced May 18, 2026
- EUDAMED 45d43a32-1e85-4e7e-9fae-005766b6fe0f 61 fields · synced May 18, 2026
- EUDAMED 092f50d4-422f-4466-aab7-66845b5e2a89 61 fields · synced May 19, 2026