Identity
- Device Name
- Reflex AFO/Drop foot Small Left EUDAMED
- Model / Reference
- 865SL EUDAMED865 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05063000865319 EUDAMED05063000865111 EUDAMED05063000865401 EUDAMED05063000865418 EUDAMED05063000865203 EUDAMED05063000865302 EUDAMED
- Basic UDI-DI
- 50630008652F EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Reflex AFO/Drop foot Small Left by Neo G Limited — 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 | 50630008652F | Class I | Active |
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Manufacturer
- Manufacturer
- Neo G Limited
- EUDAMED SRN
- GB-MF-000004603
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (6)
- EUDAMED 0dd5965a-6442-4917-9509-00299bb10769 61 fields · synced Jul 31, 2026
- EUDAMED ef0cc330-4d02-4868-853e-938cf6e39a2c 61 fields · synced May 16, 2026
- EUDAMED c0d2ca24-82c9-4732-ba63-88a1aba4a915 61 fields · synced May 19, 2026
- EUDAMED 918946af-ada3-448d-88bd-50eef573ac1c 61 fields · synced May 19, 2026
- EUDAMED 580f5b89-04f5-40c5-a88c-459f5c50af17 61 fields · synced May 19, 2026
- EUDAMED 6b0012e1-57ba-4935-8854-b71960ec0371 61 fields · synced May 19, 2026