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Neothotics Pro-Expert Full Length Orthotic Insole
EUDAMEDClass I (EU MDR)
Ref N/AModel 597
Identity
- Device Name
- NEOTHOTICS PRO-EXPERT FULL LENGTH ORTHOTIC INSOLE EUDAMED
- Model / Reference
- 597 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976425574185 EUDAMED06976425574188 EUDAMED
- Basic UDI-DI
- 697642557in4182S EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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-Expert Full Length Orthotic Insole by Dongguan Jiuhui Industrial 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 | 697642557in4182S | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Jiuhui Industrial Limited
- EUDAMED SRN
- CN-MF-000035646
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 80ce6075-0fda-44a2-8751-a6c6043a7a08 61 fields · synced Oct 6, 2026
- EUDAMED 036ff3e3-6e59-4d52-b48b-8adad5a9b355 61 fields · synced May 18, 2026