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MagPurix Viral/Pathogen Nucleic Acids Extraction Kit B (48) ST

by Zinexts Life Science Corp.

Ref 311B041A

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 Number471988968311B044S Basic UDI-DI 04719889681571UDI-DIDate28 Jan 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  • Withdrawn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
MagPurix Viral/Pathogen Nucleic Acids Extraction Kit B
Model / Reference
311B041A
Primary DI / UDI-DI
04719889681571
Basic UDI-DI
471988968311B044S
EMDN Code
W02069085 Various sample processing instruments - consumables
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000026758
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Reagent

Other properties (10)

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