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Ottix Shaper 1 Lt

by Diapath S.p.A. società a socio unico

Ref X0093Model XYLENE AND ALCOHOLS SUBSTITUTE - OTTIX SHAPER

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8033895W01030799OttixSQ7 Basic UDI-DI 08033895012553UDI-DIDate30 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Ottix Shaper
Model / Reference
XYLENE AND ALCOHOLS SUBSTITUTE - OTTIX SHAPER, X0093
Primary DI / UDI-DI
08033895012553
Basic UDI-DI
8033895W01030799OttixSQ7
Direct Marketing DI
08033895012553
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027016

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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