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AFO Leaf Spring
EUDAMEDClass I (EU MDR)
Ref 620002(S/Left/White)Model AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004Ref 620002(L/Left/White)Ref 620002(XL/Right/White)Ref 620002(XL/Left/White)Ref 620002(S/Right/White)Ref 620002(M/Right/White)
Identity
- Trade Name
- AFO Leaf Spring 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 EUDAMED620002(S/Left/White) EUDAMED620002(L/Left/White) EUDAMED620002(XL/Right/White) EUDAMED620002(XL/Left/White) EUDAMED620002(S/Right/White) EUDAMED620002(M/Right/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872865612 EUDAMED04719872865575 EUDAMED04719872865643 EUDAMED04719872865636 EUDAMED04719872865629 EUDAMED04719872865605 EUDAMED
- Basic UDI-DI
- 47198728662WN EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
AFO Leaf Spring 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 | 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 (6)
- EUDAMED 22843ad0-6b90-4b27-824a-a3d246177527 61 fields · synced Oct 8, 2026
- EUDAMED 8113e00f-12cd-4bf5-9406-22a59862048f 61 fields · synced May 17, 2026
- EUDAMED dc444d66-96b2-4891-a75a-f7db6ec6a6b0 61 fields · synced May 17, 2026
- EUDAMED 9c4c205b-2493-49e2-b1cb-80498a1c5f16 61 fields · synced May 17, 2026
- EUDAMED 5f65d3f7-6251-4e5e-8dc6-5fb17c2902f9 61 fields · synced May 18, 2026
- EUDAMED 95dedc72-d99c-4a06-85be-fa4f8335c7d7 61 fields · synced May 19, 2026