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Nucleic Acid Extraction Kit

by Bgi Europe a/S Denmark EUDAMED

Ref MFG010011Model 96 tests

EMDN W0105900102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5745000468MFG010011FN Basic UDI-DIDate11 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
96 tests, MFG010011
Primary DI / UDI-DI
05745000468089
Basic UDI-DI
5745000468MFG010011FN
EMDN Code
W0105900102 Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus
Device Class
Class A
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 40f16b8b-a67f-4921-9a59-5c473a84ac67 61 fields · synced 22 Oct 2026