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SmartStim M1000
EUDAMEDClass IIa (EU MDR)
Ref ND-1-204Model Smartstim M1000
by Nuraleve
Identity
- Trade Name
- SmartStim M1000 EUDAMED
- Device Name
- Smartstim M1000 EUDAMED
- Model / Reference
- Smartstim M1000 EUDAMEDND-1-204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628942046230 EUDAMED
- Basic UDI-DI
- 628942046230M1000PN EUDAMEDB-00628942046230 EUDAMED
- Direct Marketing DI
- 00628942046230 EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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: Point aesthesiometer
SmartStim M1000 by Nuraleve — Class IIa — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 628942046230M1000PN | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 628942046230M1000PN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nuraleve
- EUDAMED SRN
- CA-MF-000039827
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 36962a5c-0e68-4592-b0e6-0b55aa2b6e8e 61 fields · synced Jul 14, 2026
- EUDAMED 190554b5-19c8-4847-9632-e73cc4c35cfb 61 fields · synced May 18, 2026