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AFO Splint
EUDAMEDClass I (EU MDR)
Ref 620001(XL/Left/White)Model AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016Ref 620001(M/Left/White)Ref 620001(L/Right/White)Ref 620001(S/Left/White)Ref 620001(L/Left/White)Ref 620001(XL/Right/White)Ref 620001(M/Right/White)
Identity
- Trade Name
- AFO Splint 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 EUDAMED620001(XL/Left/White) EUDAMED620001(M/Left/White) EUDAMED620001(L/Right/White) EUDAMED620001(S/Left/White) EUDAMED620001(L/Left/White) EUDAMED620001(XL/Right/White) EUDAMED620001(M/Right/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964460312 EUDAMED04719964460275 EUDAMED04719964460268 EUDAMED04719964460299 EUDAMED04719964460251 EUDAMED04719964460329 EUDAMED04719964460282 EUDAMED
- Basic UDI-DI
- 47199644662WL 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 Splint 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 | 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 (7)
- EUDAMED 21570d02-55ba-40e5-b409-21ea2b3812ac 61 fields · synced Oct 6, 2026
- EUDAMED 28524902-aec9-4857-b99c-c0691052bd84 61 fields · synced May 17, 2026
- EUDAMED caad4bd7-cc82-4742-b1f1-b01a14d6dc56 61 fields · synced May 17, 2026
- EUDAMED 9ae56d68-c84f-4ae4-85de-79be1a73928d 61 fields · synced May 17, 2026
- EUDAMED 89c0eb9a-c79b-4720-bcab-17557cce32dd 61 fields · synced May 18, 2026
- EUDAMED 85be663f-bfe6-4511-9b14-467cde5923af 61 fields · synced May 19, 2026
- EUDAMED 89503ac5-5611-4985-8d55-69056ec4caf2 61 fields · synced May 19, 2026