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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry - rapid tests & point of care
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Fertility / pregnancy rt & poc
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Fertility/pregnancy rt & poc - other
Fertility/pregnancy rt & poc - other
W0102160399
114 devices
Prolactin Test (FIA)
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
medicare femSense
SteadySense GmbH
·
,
Austria
Class I
CE/MDR
PRL Rapid Quantitative Test (Chemiluminescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
TESTO Rapid Quantitative Test (Chemiluminescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
E2 Rapid Quantitative Test (Chemiluminescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accufast
Artron Laboratories Inc.
·
,
Canada
IVD for self-testing
CE/IVDD
FertiQUICK
NanoRepro AG
·
,
Germany
IVD for self-testing
CE/IVDR
D1368900058
Active
Valid to Jan 2030
CE/IVDD
PRL Rapid Test
Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HCG Test Kit(Urine)
Neo-nostics (Suzhou) Bioengineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
PRL Rapid Detect
Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
FertiQUICK (DE/EN)
NanoRepro AG
·
,
Germany
IVD for self-testing
CE/IVDD
AMH Rapid Quantitative Test (Chemiluminescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
E2 Test Kit FIA
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
E2 Rapid Detect
Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
PROG Rapid Quantitative Test (Chemiluminescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Sperm Concentration Test
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
FSH / LH Detection Kit (Immunofluorescence Chromatography)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
Huac
Tianjin HUAC Healthcare Technology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
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