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Contour Ankle Stablizer
EUDAMEDClass I (EU MDR)
Ref 628002(L/Right/Black)Model AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016Ref 628002(M/Left/Black)Ref 628002(XL/Right/Black)Ref 628002(M/Right/Black)
Identity
- Trade Name
- Contour Ankle Stablizer 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 EUDAMED628002(L/Right/Black) EUDAMED628002(M/Left/Black) EUDAMED628002(XL/Right/Black) EUDAMED628002(M/Right/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964465294 EUDAMED04719964465263 EUDAMED04719964465317 EUDAMED04719964465270 EUDAMED
- Basic UDI-DI
- 47199644662WL EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Contour Ankle Stablizer 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 (4)
- EUDAMED d838aef4-1258-4fcf-b1be-cf4feb4a5409 61 fields · synced Oct 6, 2026
- EUDAMED f47e07f4-98a3-4924-8cf4-551f4a7ab392 61 fields · synced May 17, 2026
- EUDAMED ed54707b-779f-40e6-9a2b-551a992f63b3 61 fields · synced May 18, 2026
- EUDAMED abbc7b5e-6cd4-4723-a1f7-8fd83964a4bb 61 fields · synced May 19, 2026