Skip to content

Bgi

by Bgi Europe a/S Denmark EUDAMED

Ref MFG030059Model 96 tests/kit-B

EMDN W0106010399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-MFG030059R7 Basic UDI-DIDate12 May 2022RegisteredStatusActive

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
Chromosomal Aneuploidy Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method)
Model / Reference
96 tests/kit-B, MFG030059
Primary DI / UDI-DI
D-MFG030059R7
Basic UDI-DI
B-MFG030059R7
EMDN Code
W0106010399 Chromosomal disorders tests - other
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
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e1a6c93b-c6ae-470a-886e-af800def9413 61 fields · synced 24 Oct 2026