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Precise Norm

by Giesse Diagnostics SRL

Ref 6003, 6000

Precise Norm (6003) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category assayed multicomponent controls (cc)) made by Giesse Diagnostics SRL, registered in EUDAMED on 5 Mar 2026 (Basic UDI-DI B-08053172971151), 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-08053172971151 Basic UDI-DI Date5 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  • Withdrawn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

Model / reference
6003, 6000
Primary DI / UDI-DI
08053172971151, 08053172971144
Basic UDI-DI
B-08053172971151, B-08053172971144
EMDN code
W0101050101 Assayed multicomponent controls (cc)
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 ASSAYED MULTICOMPONENT CONTROLS (CC).

Other devices from Giesse Diagnostics SRL

See all devices from Giesse Diagnostics SRL →

Properties

  • Contains human tissues or cells
  • Professional testing
Other properties (10, all answered No)