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ReadiMag Pathogen Nucleic Acid Isolation Kit

by 3D Biomedicine Science & Technology Co., Limited

Ref 3000000000358Model 32Tests/kit

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 Number697368547154Q5 Basic UDI-DI 06973685471547UDI-DIDate9 Sep 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  • Withdrawn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
ReadiMag Pathogen Nucleic Acid Isolation Kit
Model / Reference
32Tests/kit, 3000000000358
Primary DI / UDI-DI
06973685471547
Basic UDI-DI
697368547154Q5
Direct Marketing DI
06973685471547
EMDN Code
W0104080209 Manual identification kits - anaerobes, pathogens - other
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000020934
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from 3D Biomedicine Science & Technology Co., Limited

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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