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In vitro diagnostic medical devices
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Reagents
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Clinical chemistry
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Urine multiple parameters testing (cc) - lab reagents
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Multiple parameters urine testing - other
Multiple parameters urine testing - other
W01010999
78 devices
ComboStik 3
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method)
Bioteke Corporation (Wuxi) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cybow 2MAC
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
Urinalysis Strips
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cybow 3GK
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
Dus 7
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
Cybow 3
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
Urinalysis Strips
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
ComboStik 11
DFI Co., Ltd.
·
,
South Korea
IVD for self-testing
CE/IVDD
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