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Microdec Edta-Based - 1 Lt

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

Ref D0053Model DECALCIFIER FOR BONE FRAGMENTS, BOM, SMALL-MEDIUM SPECIMENS - MICRODEC EDTA-BASED

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 Number8033895W01030799D005XLQ Basic UDI-DI 08033895008969UDI-DIDate14 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  • Withdrawn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
Microdec Edta-Based
Model / Reference
DECALCIFIER FOR BONE FRAGMENTS, BOM, SMALL-MEDIUM SPECIMENS - MICRODEC EDTA-BASED, D0053
Primary DI / UDI-DI
08033895008969
Basic UDI-DI
8033895W01030799D005XLQ
Direct Marketing DI
08033895008969
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