Identity
- Trade Name
- NeuroFlex EUDAMED
- Device Name
- NeuroFlex EUDAMED
- Model / Reference
- NeuroFlex - wellness software EUDAMED
Identifiers
- Primary DI / UDI-DI
- PP11848NEUROFLEX86 EUDAMED
- Basic UDI-DI
- 628942227554GW EUDAMED
- Direct Marketing DI
- PP11848NEUROFLEX86 EUDAMED
- EMDN Code
- Z12101192 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
NeuroFlex by Saccade Analytics Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 628942227554GW | Class I | Active |
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Manufacturer
- Manufacturer
- Saccade Analytics Inc.
- EUDAMED SRN
- CA-MF-000030210
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 1987e480-8dc0-4bfa-a13f-6db9132b89b2 61 fields · synced Aug 2, 2026