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Nucleic Acid Extration Kit(Magnetic Bead Method)

by Zybio Inc. EUDAMED

Active European Union

Ref 01.09.20.05.ET.06Model FFPE-B, FFPE-T

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69732628600035ZR Basic UDI-DIDate1 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Nucleic Acid Extration Kit(Magnetic Bead Method)
Model / Reference
FFPE-B, FFPE-T, 01.09.20.05.ET.06
Primary DI / UDI-DI
06973262860467
Market of Registration
Netherlands

Manufacturer details

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

Other devices from Zybio Inc.

See all devices from Zybio Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06973262860467|69732628600035ZR 61 fields · synced 24 Oct 2026