Skip to content

Simplexa™ Bordetella Universal Direct

by DiaSorin Molecular LLC 2 variants

Ref MOL2700

Simplexa™ Bordetella Universal Direct (MOL2700) is a device classified as IVD General made by DiaSorin Molecular LLC, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-20816101025811), 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-20816101025811 Basic UDI-DI 20816101025811UDI-DIDate30 Oct 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  • Withdrawn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
MOL2700
Primary DI / UDI-DI
20816101025811
Basic UDI-DI
B-20816101025811
EMDN code
W0105011607 Bordetella pertussis / parapertussis - na reagents
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000042006
Authorised representative
DiaSorin Italia S.p.A. IT-AR-000029423

Similar devices in this category

Other devices filed under OTHER BACTERIOLOGY - NA REAGENTS.

Other devices from DiaSorin Molecular LLC

See all devices from DiaSorin Molecular LLC →

Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)