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EasyPrep electrodes

by Neurowave Systems, Inc.

Ref EK-901Model EasyPrep Sensor Kit

EasyPrep electrodes (EK-901) is a device classified as Class I in the EU and Class II in the US made by Neurowave Systems, Inc., registered in EUDAMED on 3 Sep 2025 (Basic UDI-DI ++B746EK901UT), cleared under FDA 510(k) K202621 on 5 Aug 2021 and listed in FDA GUDID since 2 Nov 2023 (UDI-DI ++B746EK901), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

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 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K202621

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B746EK901UT Basic UDI-DI ++B746EK901UDI-DIDate3 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number++B746EK901 UDI-DI Date2 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202621 Date5 Aug 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++B746EK901UT registered 3 Sep 2025 Active
  • FDA 510(k) K202621 decided 5 Aug 2021 Active
  • FDA GUDID UDI-DI ++B746EK901 listed 2 Nov 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K202621
  2. Listed FDA GUDID ++B746EK901
  3. Registered EUDAMED ++B746EK901UT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
EasyPrep electrodes EUDAMED
EasyPrep Sensor Kit GUDID
Generic name
Analytical scalp electrode, single-use
Device name
Electrodes
Model / Ref / Catalog
EasyPrep Sensor Kit, EK-901
Primary DI / UDI-DI
++B746EK901 EUDAMED
B746EK9011 GUDID
Basic UDI-DI
++B746EK901UT
510(k) Number
FDA product code
GXY
EMDN code
N01010299 EEG electrodes - other
GMDN term
Analytical scalp electrode, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
++B746EK901
GUDID
B746EK9011
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists ++B746EK901; FDA GUDID lists B746EK9011), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000030995
Authorised representative
AF Pharma Service Europe SL ES-AR-000018076

Similar devices in this category

Other devices filed under EEG ELECTRODES - OTHER.

Other devices from Neurowave Systems, Inc.

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)