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Viasure

by Certest Biotec S.L. EUDAMED

Active European Union

Ref 444224Model VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System (2x12 tubes, 24 test)

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number84354402MDXRESISTC_BMGMHP Basic UDI-DIDate16 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System
Model / Reference
VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System (2x12 tubes, 24 test), 444224
Primary DI / UDI-DI
08435440258704
Basic UDI-DI
84354402MDXRESISTC_BMGMHP
EMDN Code
W010501080302 Urogenital mycoplasma detection by na reagents
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000002193

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See all devices from Certest Biotec S.L. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No