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NeoThotics Pro-Flex Full Length Slimline Insoles - Small/Medium
EUDAMEDClass I (EU MDR)
Ref 596Model 596S/M
Identity
- Device Name
- NeoThotics Pro-Flex Full Length Slimline Insoles - Small/Medium EUDAMED
- Model / Reference
- 596S/M EUDAMED596 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05063000596121 EUDAMED
- Basic UDI-DI
- 50630005962B 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-Flex Full Length Slimline Insoles - Small/Medium by Neo G Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 50630005962B | 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 (1)
- EUDAMED 7eeacc5c-3756-4ec2-b034-2f63cb9ec191 61 fields · synced Jul 11, 2026