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recomLine Treponema IgG

by Mikrogen GmbH 2 variants

Ref 5170

recomLine Treponema IgG (5170) is a device classified as IVD General made by Mikrogen GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-04250571111759), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04250571111759 Basic UDI-DI 04250571111759UDI-DIDate5 Nov 2026RegisteredStatusActive

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  • Withdrawn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
5170
Primary DI / UDI-DI
04250571111759
Basic UDI-DI
B-04250571111759
EMDN code
W0105010303 Syphilis antibody igg
Device class
Class IVD General
EU registration type
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 SYPHILIS (TREPONEMA PALLIDUM).

Other devices from Mikrogen GmbH

See all devices from Mikrogen GmbH →

Properties

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