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In vitro diagnostic medical devices
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IVD generic use consumables
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Devices for samples analyses (no laboratory generic products)
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Devices for samples analyses - various
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Devices for samples analyses - other
Devices for samples analyses - other
W05039099
307 devices
CONFIRM 3, +25%, 50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES IX 3X Cutoff, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Uriglass
Biosigma S.P.A.
·
,
Italy
Class A
CE/IVDR
hCG Low positive / Negative URINE 2x5mL Kitbox
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 30 micron, 4 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
DOA-SKREEN POSITIVE CONTROL, 6x10mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SSHMOBE with Butalbital Cutoff -50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ORAL-SKREEN NEGATIVE, 500mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Bioanalytic, 100µm, Neubauer improved
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
SERIES IV-H 3X Cutoff 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
BIRR, 20µm, Sperm Counting Grid
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
STAT-SKREEN-H with MDMA, OXY & BUP 2x5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ORAL-SKREEN, 3X Cutoff, 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MES, 20µm, Slides voor Vision
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
ISAS, 20µm, 4-chambers horizontal
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
MammaPrint FFPE microarray
Agendia N.V
·
,
Netherlands
Class C
CE/IVDR
GUDID
on market
CONFIRM 4, Cutoff -60%, 10x50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES V CUTOFF +25% 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Streck
Streck
·
,
United States
Class B
CE/IVDR
GUDID
on market
CellVision, 100 micron, 6 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
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