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recomLine Chlamydia IgA [IgM]

by Mikrogen GmbH

Ref 6173

recomLine Chlamydia IgA [IgM] (6173) is a device classified as Class C (EU), IVD Annex II List B (EU) made by Mikrogen GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 42505711B2106WS), 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/IVDD Number42505711B2106WS Basic UDI-DI 04250571101200UDI-DIDate5 Nov 2026RegisteredStatusActive
European UnionCE/IVDR Number42505711B2106WS Basic UDI-DI 04250571101200UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Model / reference
6173
Primary DI / UDI-DI
04250571101200
Basic UDI-DI
42505711B2106WS, B-04250571101200
EMDN code
W0105010199 Chlamydia reagents - other
Device class
Class C
Class IVD Annex II List B
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000027747

Similar devices in this category

Other devices filed under CHLAMYDIA.

Other devices from Mikrogen GmbH

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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)