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D-Dimero

by Giesse Diagnostics SRL

Ref 6737

D-Dimero (6737) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category D-dimer) made by Giesse Diagnostics SRL, registered in EUDAMED on 31 Mar 2026 (Basic UDI-DI B-08053172971922), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08053172971922 Basic UDI-DI 08053172971922UDI-DIDate31 Mar 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  • Withdrawn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

Device name
D-Dimero/D-Dimer
Model / reference
6737
Primary DI / UDI-DI
08053172971922
Basic UDI-DI
B-08053172971922
EMDN code
W0103020503 D-dimer
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000039031

Similar devices in this category

Other devices filed under D-DIMER.

Other devices from Giesse Diagnostics SRL

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)