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IgM Reagent

by Aidian Oy

Ref 67732

IgM Reagent (67732) is a device classified as IVD General made by Aidian Oy, registered in EUDAMED on 11 Aug 2022 (Basic UDI-DI B-06438115000501), active as of 22 Oct 2026.

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06438115000501 Basic UDI-DI 06438115000501UDI-DIDate11 Aug 2022RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
67732
Primary DI / UDI-DI
06438115000501
Basic UDI-DI
B-06438115000501
EMDN code
W0102010107 Immunoglobulin m
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000023611

Similar devices in this category

Other devices filed under IMMUNOGLOBULIN M.

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)