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NeoThotics Pro-Silicone Heel Cushion Orthotic Insole - Small
EUDAMEDClass I (EU MDR)
Ref 594Model 594S
Identity
- Device Name
- NeoThotics Pro-Silicone Heel Cushion Orthotic Insole - Small EUDAMED
- Model / Reference
- 594S EUDAMED594 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05063000594202 EUDAMED05063000594103 EUDAMED05063000594301 EUDAMED
- Basic UDI-DI
- 506300059427 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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: Orthotic insole, prefabricated, non-antimicrobial
NeoThotics Pro-Silicone Heel Cushion Orthotic Insole - Small by Neo G Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 506300059427 | 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 (3)
- EUDAMED 77c36416-7e3f-4593-a381-790682bf4002 61 fields · synced Aug 1, 2026
- EUDAMED 961a0239-c30c-4a3e-b71e-5f5be012daad 61 fields · synced May 17, 2026
- EUDAMED f2a1faff-b6c6-4fe1-acba-485ce6d3f7df 61 fields · synced May 17, 2026