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Nucleic Acid Extraction Kit

by BGl Biotechnology (Wuhan) Co., Ltd EUDAMED

Active European Union

Ref MFG010109Model 400 tests/kit

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697478304MFG01010944 Basic UDI-DIDate24 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
Nucleic Acid Extraction Kit
Model / Reference
400 tests/kit, MFG010109
Primary DI / UDI-DI
06974783042905
Basic UDI-DI
697478304MFG01010944
Direct Marketing DI
06974783042905
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000050469
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from BGl Biotechnology (Wuhan) Co., Ltd

See all devices from BGl Biotechnology (Wuhan) Co., Ltd →

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