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Rosa Bengala

by Giesse Diagnostics SRL

Ref 7802, 7802/50

Rosa Bengala (7802) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category brucella) made by Giesse Diagnostics SRL, registered in EUDAMED on 6 Mar 2026 (Basic UDI-DI B-08053172971540), 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-08053172971540 Basic UDI-DI Date6 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  • Withdrawn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
Rosa Bengala/Bengal Rose
Model / reference
7802, 7802/50
Primary DI / UDI-DI
08053172971540, 08053172970338
Basic UDI-DI
B-08053172971540, B-08053172970338
EMDN code
W0105011701 Brucella
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

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Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (7, all answered No)