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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
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Haemostasis reagents (coagulation)
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Haemostasis reagents - other
Haemostasis reagents - other
W01030299
18 devices
Devices
Ap
APIRO Diagnostics Kft.
·
,
HU
Class C
CE/IVDR
2025-IVDR/QS-007/A
Active
Valid to Oct 2030
Clotting Tetrachoric Combined Testing Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Fib
APIRO Diagnostics Kft.
·
,
HU
Class C
CE/IVDR
2025-IVDR/QS-007/A
Active
Valid to Oct 2030
Hi
APIRO Diagnostics Kft.
·
,
HU
Class C
CE/IVDR
2025-IVDR/QS-007/A
Active
Valid to Oct 2030
Ex
APIRO Diagnostics Kft.
·
,
HU
Class C
CE/IVDR
2025-IVDR/QS-007/A
Active
Valid to Oct 2030
Cn-Coagwasher
Sysmex Corporation
·
,
JP
Class A
CE/IVDR
In
APIRO Diagnostics Kft.
·
,
HU
Class C
CE/IVDR
2025-IVDR/QS-007/A
Active
Valid to Oct 2030
Rvv
APIRO Diagnostics Kft.
·
,
HU
Class C
CE/IVDR
2025-IVDR/QS-007/A
Active
Valid to Oct 2030
sthemO Pool Norm
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
Clotting Tetrachoric Combined Testing Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Tpa
APIRO Diagnostics Kft.
·
,
HU
Class C
CE/IVDR
2025-IVDR/QS-007/A
Active
Valid to Oct 2030
Ca Cal S
Sysmex Corporation
·
,
JP
Class A
CE/IVDR
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