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Gram

by Bio-Optica Milano S.p.A. 3 variants

Ref 04-100804Model Staining kit for microbiology

Active European Union

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number080339762W0104010899D7 Basic UDI-DI 08033976231088UDI-DIDate6 Oct 2022RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
Staining kit for microbiology, 04-100804
Primary DI / UDI-DI
08033976231088
Basic UDI-DI
080339762W0104010899D7
Direct Marketing DI
08033976231088
EMDN Code
W0104010899 Buffers, stains - other
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027525

Other devices from Bio-Optica Milano S.p.A.

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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