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Athena Ankle Support
EUDAMEDClass I (EU MDR)
Ref 622003(XL/UNI/Blue)Model AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004Ref 620001(M/Right/White)Ref 622004(M/UNI/Blue)Ref 622003(2XL/UNI/Blue)Ref 622003(M/UNI/Blue)Ref 622004(S/UNI/Blue)Ref 622004(XL/UNI/Blue)
Identity
- Trade Name
- Athena Ankle Support EUDAMEDAFO Splint EUDAMEDAthena Ankle Support Pro EUDAMED
- Device Name
- Ankle Brace, Ankle Foot Orthosis, Night Splint (Ankle/foot orthosis) EUDAMED
- Model / Reference
- AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004 EUDAMED622003(XL/UNI/Blue) EUDAMED620001(M/Right/White) EUDAMED622004(M/UNI/Blue) EUDAMED622003(2XL/UNI/Blue) EUDAMED622003(M/UNI/Blue) EUDAMED622004(S/UNI/Blue) EUDAMED622004(XL/UNI/Blue) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892930857 EUDAMED04719872865520 EUDAMED04719892930871 EUDAMED04719892933131 EUDAMED04719892930833 EUDAMED04719892930864 EUDAMED04719892930895 EUDAMED
- Basic UDI-DI
- 47198728662WN EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDGreece 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
Category: Ankle/foot orthosis
Athena Ankle Support by Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 47198728662WN | 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 (7)
- EUDAMED f3be53ef-fd69-46e9-98b9-711c42614321 61 fields · synced Oct 6, 2026
- EUDAMED 6e2e7bf2-eb14-46db-8e50-43f3ade1c5ee 61 fields · synced May 17, 2026
- EUDAMED fe6f85fc-436f-4c2b-b416-ea7527be644c 61 fields · synced May 17, 2026
- EUDAMED 93535581-f1ad-4dc5-be4f-f3915ebe385f 61 fields · synced May 17, 2026
- EUDAMED b9ea177c-18b4-42ff-bc95-0bd6652ec6b9 61 fields · synced May 18, 2026
- EUDAMED ced82e4c-0ffa-4c57-9c21-dcc1775a2a1e 61 fields · synced May 18, 2026
- EUDAMED 4b8abcc4-4d3e-4e0c-a714-226567139dcb 61 fields · synced May 19, 2026