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In vitro diagnostic medical devices
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IVD instruments
/
Hematology / histology / cytology instruments
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Hemostasis
/
Various hemostasis instruments
/
Various hemostasis instruments - other
Various hemostasis instruments - other
W0202029099
37 devices
Devices
STA R Max® 3
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
STA R Max® 3
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
Thrombo-Aggregometer
SD Innovation
·
,
FR
Class A
CE/IVDR
ST Genesia®
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
UniTip Applicator
H.+H. Maslanka Chirurgische Instrumente GmbH
·
,
DE
Class IIa
CE/MDR
1000225429
Active
Valid to Sep 2031
STA Compact Max® 3
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
Quantra Hemostasis Analyzer
Hemosonics LLC
·
,
US
Class A
FDA De Novo
DEN180017
Active
Cleared 12 Mar 2019
FDA 510(k)
K230461
Active
Cleared 24 Mar 2023
+2
authorizations
Chrono-log® Whole Blood Lumi-Aggregometer
Chrono-Log Corp
·
,
US
Class A
CE/IVDR
GUDID
on market
CHRONO-LOG® Optical Aggregometer
Chrono-Log Corp
·
,
US
Class A
CE/IVDR
GUDID
on market
STA Compact Max® 2
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
GUDID
on market
STA R Max® 3
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
Thrombo-Aggregometer
SD Innovation
·
,
FR
Class A
CE/IVDR
STA R Max® 3
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
T-TAS wS
Zacros Corporation
·
,
JP
Class A
CE/IVDR
STA R Max®
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
GUDID
on market
sthemO 301
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
CHRONO-LOG(R) Whole Blood Lumi-Aggregometer
Chrono-Log Corp
·
,
US
Class A
FDA 510(k)
K771198
Active
Cleared 2 Aug 1977
CE/IVDR
+1
authorizations
sthemO 201
Diagnostica Stago
·
,
FR
Class A
CE/IVDR
UniTip Applicator
H.+H. Maslanka Chirurgische Instrumente GmbH
·
,
DE
Class IIa
CE/MDR
1000225429
Active
Valid to Sep 2031
STA Compact Max® 3
Diagnostica Stago
·
,
FR
Class A
CE/MDR
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