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Safecapsule – Formalin (15 Ml) 36 Pcs

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

Active European Union

Ref SC092Model SINGLE-USE BOTTLE PRE-FILLED WITH BUFFERED FORMALDEHYDE FOR THE FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8033895W01030705SafCap2X Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Safecapsule
Model / Reference
SINGLE-USE BOTTLE PRE-FILLED WITH BUFFERED FORMALDEHYDE FOR THE FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS, SC092
Primary DI / UDI-DI
08033895011082
Basic UDI-DI
8033895W01030705SafCap2X
Direct Marketing DI
08033895011082
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class A
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