164 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Denmark
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ELDONBOX 2521 ID-25
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Eldon Biologicals A/S·On the market
ELDONBOX 2521 ID-100
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Eldon Biologicals A/S·On the market
ELDON BAG 2521 ID-10
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Eldon Biologicals A/S·On the market
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELDONBOX 2521 ID-100
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Eldon Biologicals A/S·1 device
ELDON BAG 2521 ID-10
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Eldon Biologicals A/S·1 device
ELDON BAG 2521 ID-25
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Eldon Biologicals A/S·1 device
ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Enforcement
Class II
·Terminated·Radiometer Medical ApS·July 8, 2020
ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Enforcement
Class II
·Terminated·Radiometer Medical ApS·July 8, 2020
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Enforcement
Class II
·Terminated·Radiometer Medical ApS·April 29, 2020
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Enforcement
Class II
·Terminated·Radiometer Medical ApS·April 29, 2020
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:
FDA Enforcement
Class II
·Terminated·Radiometer Medical ApS·April 15, 2020
Cardia International A/S
Manufacturer
🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS
Device
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·On the market·1 country
EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS
Device
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·On the market·1 country
CardiAid®
Device
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·On the market·2 countries
BLOSTRUPMOEN®
Device
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·On the market·1 country
CardiAid®
Device
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·On the market·2 countries