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8-CH Electroencephalography Amplifier
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref EAmp-0001
Identity
- Trade Name
- 8-CH Electroencephalography Amplifier EUDAMED
- Device Name
- 8-CH Electroencephalography Amplifier EUDAMED
- Model / Reference
- EAmp-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719897969012 EUDAMED
- Basic UDI-DI
- 471989796EAmp0001US EUDAMED
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
8-CH Electroencephalography Amplifier by HippoScreen Neurotech Corp — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201747 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 471989796EAmp0001US | 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 (2)
- EUDAMED 01f7577d-a2a9-4e1e-9005-a6b1bada8e4d 61 fields · synced Jul 9, 2026
- FDA 510(k) K201747 1 fields · synced May 18, 2026