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In vitro diagnostic medical devices
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Clinical chemistry
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Clinical chemistry - rapid tests & poc
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Urine testing (cc) - rt & poc
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Urine multi-constituent test strips (manual)
Urine multi-constituent test strips (manual)
W0101060204
318 devices
Reagent strips for urinalysis
Yercon Diagnostic Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Urine Analysis Test (Urine)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Reagent strips for urinalysis
Yercon Diagnostic Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Reagent strips for urinalysis
Yercon Diagnostic Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Accu-Tell® Urine Reagent Strips 10Para
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Reagent strips for urinalysis
Yercon Diagnostic Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Urine Reagent Strips
URIT Medical Electronic Co., Ltd.
·
,
China
Class B
CE/IVDR
URiSCAN® 2 Gluketo strip
YD Diagnostics CORP.
·
,
South Korea
Class B
CE/IVDR
Urinalysis Reagent Strips
Hangzhou Bosure Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
Uritrak - 1, 2, 3, 5 and 10
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
Egypt
IVD General
CE/IVDD
Urine Reagent Strips
URIT Medical Electronic Co., Ltd.
·
,
China
Class B
CE/IVDR
Urinary Tract Infection Self Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD for self-testing
FDA 510(k)
K252607
Active
Cleared 30 Oct 2025
CE/IVDD
See Now 6 DOA panel
S.C. Camp Medica Distribution SRL
·
,
Romania
IVD General
CE/IVDD
Reagent strips for urinalysis
Yercon Diagnostic Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Glu/Ket/PH/Blood/Pro/Bili/Urobil/ S.Gravity/ Nit/Leukocytes Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Reagent strips for urinalysis
Yercon Diagnostic Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Reagent strips for urinalysis
Yercon Diagnostic Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Urinalysis Strips
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Accu-Tell® Urine Reagent Strips 2Para
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Urinalysis Strips
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
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