17 results · 22ms · Sources: EU EUDAMED, US FDA

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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