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Data Analysis Software

by Megin Oy

Ref SW23380N

Data Analysis Software (SW23380N) is a device classified as Class IIa in the EU and Class II in the US made by Megin Oy, registered in EUDAMED on 29 Apr 2024 (Basic UDI-DI B-06430056480022) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 06430056480022), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06430056480022 Basic UDI-DI 06430056480022UDI-DIDate29 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06430056480022 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06430056480022 registered 29 Apr 2024 Active
  • FDA GUDID UDI-DI 06430056480022 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06430056480022
  2. Registered EUDAMED B-06430056480022

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Data analysis software 3.4
Generic name
Electroencephalograph
Device name
Data Analysis Software
Model / reference
SW23380N
Primary DI / UDI-DI
06430056480022
Basic UDI-DI
B-06430056480022
FDA product code
OLX
EMDN code
Z12101292 Magnetoencephalography instruments – medical device software
GMDN term
Electroencephalograph
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400
EU registration type
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
FI-MF-000011965

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Properties

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