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BRCA1 and BRCA2 Gene Mutation Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method)

by Bgi Europe a/S Denmark EUDAMED

Ref MFG030013, MFG030019Model 32 tests/kit, 64tests/kit

EMDN W01060203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05745000468034 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
BRCA1 and BRCA2 Gene Mutation Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method)
Model / Reference
32 tests/kit, 64tests/kit, MFG030013, MFG030019
Primary DI / UDI-DI
05745000468034
Basic UDI-DI
B-05745000468034
EMDN Code
W01060203 Brca 1+2
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 05745000468034|B-05745000468034 61 fields · synced 24 Oct 2026