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In vitro diagnostic medical devices
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Inborn gene or chromosome alterations
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Multiple detection of chromosomal disorders tests
Multiple detection of chromosomal disorders tests
W0106010306
6 devices
Devices
STaR Optima 1
Cybergene AB
·
,
SE
IVD General
CE/IVDD
IONA® test M (including software)
Yourgene Health UK Ltd
·
,
GB
IVD Annex II List B
CE/IVDD
Nifty®
Bgi Europe A/S
·
,
DK
Class C
CE/IVDR
Yourgene® QST*R Base
Yourgene Health UK Ltd
·
,
GB
Class C
CE/IVDR
IONA® Test AR (including software)
Yourgene Health UK Ltd
·
,
GB
IVD Annex II List B
CE/IVDD
IONA® Nx cfDNA Library Prep Dx Kit (96) (including software)
Yourgene Health UK Ltd
·
,
GB
IVD Annex II List B
CE/IVDD
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