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recomLine HEV IgG/IgM

by Mikrogen GmbH 2 variants

Ref 5070

recomLine HEV IgG/IgM (5070) is a device classified as IVD General (EU), Class C (EU) made by Mikrogen GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-04250571111438), active as of 7 Nov 2026.

Active European Union

CE IVDR CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-04250571111438 Basic UDI-DI 04250571111438UDI-DIDate5 Nov 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-04250571111438 Basic UDI-DI 04250571111438UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Model / reference
5070
Primary DI / UDI-DI
04250571111438
Basic UDI-DI
B-04250571111438, 42505711B2215WY
EMDN code
W0105020503 Hev antibody (total)
Device class
Class IVD General
Class C
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000027747

Similar devices in this category

Other devices filed under HEPATITIS E VIRUS.

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • IVD kit
  • Professional testing
Other properties (9, all answered No)