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Ankle Brace With Strap
EUDAMEDClass I (EU MDR)
Ref 620017(XL/UNI/Black)Model AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016Ref 620008(L/UNI/Gray&Silver)Ref 620008(S/UNI/Gray&Silver)Ref 620008(M/UNI/Gray&Silver)Ref 620009(M/UNI/Gray&Silver)Ref 620009(L/UNI/Gray&Silver)Ref 620008(XL/UNI/Gray&Silver)Ref 620017(M/UNI/Black)
Identity
- Trade Name
- Ankle Brace With Strap EUDAMED
- Device Name
- Ankle Brace, Ankle Foot Orthosis, Night Splint (Ankle/foot orthosis) EUDAMED
- Model / Reference
- AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016 EUDAMED620017(XL/UNI/Black) EUDAMED620008(L/UNI/Gray&Silver) EUDAMED620008(S/UNI/Gray&Silver) EUDAMED620008(M/UNI/Gray&Silver) EUDAMED620009(M/UNI/Gray&Silver) EUDAMED620009(L/UNI/Gray&Silver) EUDAMED620008(XL/UNI/Gray&Silver) EUDAMED620017(M/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964465065 EUDAMED04719964460626 EUDAMED04719964460640 EUDAMED04719964460633 EUDAMED04719964460671 EUDAMED04719964460664 EUDAMED04719964460657 EUDAMED04719964465041 EUDAMED
- Basic UDI-DI
- 47199644662WL EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDGreece 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
Category: Ankle/foot orthosis
Ankle Brace With Strap by Orthotech 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 | 47199644662WL | 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 (8)
- EUDAMED d2a84752-bdad-4e4b-8422-b07588f9c3e8 61 fields · synced Aug 2, 2026
- EUDAMED 7f3407a9-101e-41e9-a7b1-e4e7b45153c8 61 fields · synced May 16, 2026
- EUDAMED fd4d0251-12b0-45c1-bbe3-7dbbd2bffc2d 61 fields · synced May 16, 2026
- EUDAMED 7f1d54de-3656-4197-b5fc-57d3dd1183f5 61 fields · synced May 17, 2026
- EUDAMED 9f12cefd-fb7a-41a5-9639-6e97dcf77ec0 61 fields · synced May 17, 2026
- EUDAMED cbac4334-cd29-43a3-8ede-0615abbb05d5 61 fields · synced May 17, 2026
- EUDAMED 14e39297-1468-479d-a2e6-230bc465856a 61 fields · synced May 18, 2026
- EUDAMED 3e400050-5391-4a13-b66f-cac62aeb4487 61 fields · synced May 19, 2026