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Nucleic Acid Extraction Kit (Magnetic Bead Method)

by Zybio Inc. China EUDAMED

Ref 0304731Model FD-A, FR-A, FDR-A, FD-T FD-B, FR-B, FDR-B, FDR-B, FR-B

EMDN W02069099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69732628600140ZP Basic UDI-DIDate1 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Nucleic Acid Extraction Kit (Magnetic Bead Method)
Model / Reference
FD-A, FR-A, FDR-A, FD-T FD-B, FR-B, FDR-B, 0304731
Primary DI / UDI-DI
06941967240051
Basic UDI-DI
69732628600140ZP
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

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 06941967240051|69732628600140ZP 61 fields · synced 24 Oct 2026