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MaxFilter™

by Megin Oy

Ref SW24051N

MaxFilter™ (SW24051N) is a device classified as Class IIa in the EU and Class II in the US made by Megin Oy, cleared under FDA 510(k) K233985 on 15 May 2024, registered in EUDAMED on 19 Apr 2024 (Basic UDI-DI B-06430056480039) and listed in FDA GUDID since 23 May 2025 (UDI-DI 06430056480039), active as of 22 Oct 2026.

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

CE MDD 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 linked in EUDAMED

A group certificate may exist

510(k) K233985

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06430056480039 UDI-DI Date23 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK233985 Date15 May 2024DecidedStatusActive
European UnionCE/MDD EUDAMED NumberB-06430056480039 Basic UDI-DI 06430056480039UDI-DIDate19 Apr 2024RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K233985 decided 15 May 2024 Active
  • EUDAMED Basic UDI-DI B-06430056480039 registered 19 Apr 2024 Active
  • FDA GUDID UDI-DI 06430056480039 listed 23 May 2025 Listed

Timeline

3 dated events

  1. Registered EUDAMED B-06430056480039
  2. Cleared FDA 510(k) K233985
  3. Listed FDA GUDID 06430056480039

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MaxFilter™ EUDAMED
MaxFilter™ 2.2 GUDID
Generic name
Magnetoencephalography system, superconducting
Device name
MaxFilter™ Software
Model / reference
SW24051N
Primary DI / UDI-DI
06430056480039
Basic UDI-DI
B-06430056480039
510(k) Number
FDA product code
OLY
EMDN code
Z12101292 Magnetoencephalography instruments – medical device software
GMDN term
Magnetoencephalography system, superconducting
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)