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8-CH Electroencephalography Amplifier

by HippoScreen Neurotech Corp

Ref EAmp-0001

8-CH Electroencephalography Amplifier (EAmp-0001) is a medical device (EU MDR Class IIa; EMDN category electroencephalographs) made by HippoScreen Neurotech Corp, registered in EUDAMED on 10 Apr 2024 (Basic UDI-DI 471989796EAmp0001US) and cleared under FDA 510(k) K201747 on 27 Dec 2020, active as of 25 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201747↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471989796EAmp0001US Basic UDI-DI 04719897969012UDI-DIDate10 Apr 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK201747 Date27 Dec 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 471989796EAmp0001US registered 10 Apr 2024 Active
  • FDA 510(k) K201747 decided 27 Dec 2020 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K201747
  2. Registered EUDAMED 471989796EAmp0001US

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / reference
EAmp-0001
Primary DI / UDI-DI
04719897969012
Basic UDI-DI
471989796EAmp0001US
EMDN code
Z12100302 Electroencephalographs
Device class
Class IIa
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
TW-MF-000040551
Authorised representative
Luana Med. B.V. NL-AR-000002750

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHS.

Other devices from HippoScreen Neurotech Corp

Properties

  • Measuring function
Other properties (13, all answered No)