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Safecapsule – Buffer Solution (100 Ml) 36 Pcs

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

Ref SC121Model SINGLE-USE BOTTLE PRE-FILLED WITH BUFFERED FORMALDEHYDE FOR THE FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS

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 Number8033895W01030705SafCap2X Basic UDI-DI 08033895011099UDI-DIDate6 May 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  • Withdrawn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
Safecapsule
Model / Reference
SINGLE-USE BOTTLE PRE-FILLED WITH BUFFERED FORMALDEHYDE FOR THE FIXATION AND TRANSPORT OF HISTOLOGICAL SPECIMENS, SC121
Primary DI / UDI-DI
08033895011099
Basic UDI-DI
8033895W01030705SafCap2X
Direct Marketing DI
08033895011099
EMDN Code
W01030799 Histology / cytology reagents - other
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