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Stress Electroencephalography Assessment System
EUDAMEDClass IIa (EU MDR)
Ref SEA-0001
Identity
- Trade Name
- Stress Electroencephalography Assessment System EUDAMED
- Device Name
- Stress Electroencephalography Assessment System EUDAMED
- Model / Reference
- SEA-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719897969029 EUDAMED
- Basic UDI-DI
- 471989796SEA0001VC EUDAMED
- EMDN Code
- Z12100392 ELECTROENCEPHALOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Stress Electroencephalography Assessment System by HippoScreen Neurotech Corp — Class IIa — 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 | 471989796SEA0001VC | Class IIa | Active |
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Manufacturer
- Manufacturer
- HippoScreen Neurotech Corp
- EUDAMED SRN
- TW-MF-000040551
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED 73bbeafd-0df3-4de6-bd73-794766bfd7ef 61 fields · synced Jul 9, 2026