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Universal Nucleic Acid Extraction Kit (Magnetic Bead Method)

by Zybio Inc. EUDAMED

Active European Union

Ref 0302016

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69732628600113ZL Basic UDI-DIDate1 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Universal Nucleic Acid Extraction Kit (Magnetic Bead Method)
Model / Reference
0302016
Primary DI / UDI-DI
06941967236429
Basic UDI-DI
69732628600113ZL
EMDN Code
W02069099 Various sample processing instruments - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000003349
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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