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In vitro diagnostic medical devices
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Urine multiple parameters testing (cc) - lab reagents
Urine multiple parameters testing (cc) - lab reagents
W010109
121 devices
Subcategories
3
W01010901
Urine multi-constituent test strips / cassettes (automated)
26
devices
W01010902
Urine sediment test kit (automated)
17
devices
W01010999
Multiple parameters urine testing - other
78
devices
Devices
Cybow 5NL
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
Dus 13
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
ComboStik 5L
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
KEYU Urine Reagent Strips
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
China
IVD General
CE/IVDD
Urinalysis Strips
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
KEYU Dry Chemistry Strip
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
China
IVD General
CE/IVDD
ComboStik 11M
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
Uf-Cellpack Cr
Sysmex Corporation
·
,
Japan
Class A
CE/IVDR
GUDID
on market
Urinalysis Strips
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
UF- Fluorocell SF
Sysmex Corporation
·
,
Japan
Class A
CE/IVDR
ComboStik 10M
DFI Co., Ltd.
·
,
South Korea
Class B
CE/IVDR
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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