17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Denmark
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Cardia International A/S
Manufacturer
🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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
1ML ONCE Luer Centric Clear Non-sterile
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·CODAN Medical ApS·1 device
1 ML CODAN PRIMO TBC Luer Centrisk Clear Sterile
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·CODAN Medical ApS·85 devices
Con-Lens
Importer
🇩🇰 Denmark·6 Manufacturers
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
FDA Enforcement
Class II
·Ongoing·Radiometer Medical ApS·May 25, 2022
CardiAid® Semi-Automatic External Defibrillator
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·1 device
CardiAid Electrodes- Pediatric
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·1 device
Cardiaid Electrodes- Adult
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·1 device
Blostrupmoen® Fully Automatic External Defibrillator
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·1 device
CardiAid® Fully Automatic External Defibrillator
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Cardia International A/S·1 device
1969/MDD
Certificate
MDD Annex II (excluding section 4)·Cardia International A/S·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·5 Basic UDI-DIs