16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Italy
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Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
FDA Enforcement
Class III
·Terminated·Sentinel CH SpA·October 13, 2021
Formalina Neutra Tamponata 4%
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
DIFF STAIN QUICK KIT
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
MP@web
Device
EU MDR
·
Eu Md Class 1
·PRO DATA S.r.l.·On the market
SOLUZIONE DI LUGOL
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
MAY-GRÜNWALD
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
GIEMSA
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
EMATOSSILINA SECONDO HARRIS
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
PAPANICOLAOU SOLUZIONE EA50
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
PAPANICOLAOU SOLUZIONE OG6
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
Biolife Italiana srl
Importer
🇮🇹 Italy·4 Manufacturers
Xmed-PR
System producer
🇮🇹 Italy
SOLUZIONI COLORANTI (ISTOLOGIA/CITOLOGIA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·5 devices
MP@web
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·PRO DATA S.r.l.·1 device
REAGENTI FISSAZIONE (ISTOLOGIA/CITOLOGIA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·2 devices
SOLUZIONI COLORANTI (ISTOLOGIA/CITOLOGIA) KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·1 device