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ClassiX DNA/RNA

by Xpedite Diagnostics GmbH EUDAMED

Active European Union

Ref CXDR-96-IVDModel ClassiX DNA/RNA

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberPP12579CLASSIX.DNA.RNA66 Basic UDI-DIDate16 Oct 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  • Withdrawn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
ClassiX DNA/RNA
Model / Reference
ClassiX DNA/RNA, CXDR-96-IVD
Primary DI / UDI-DI
112094276736
Basic UDI-DI
PP12579CLASSIX.DNA.RNA66
EMDN Code
W0105011699,W01050499,W0105050399,W0105060499,W0105070201,W02050106
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000020021

From the manufacturer

Manufacturer's product page: ClassiX™ DNA/RNA | NEW

Other devices from Xpedite Diagnostics GmbH

See all devices from Xpedite Diagnostics GmbH →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (8)

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