21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Denmark
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Innoventa Medica ApS
Manufacturer
🇩🇰 Denmark·3 Basic UDI-DIs·8 Devices·Intertek Medical Notified Body AB, Intertek Medical Notified Body AB, and Intertek Medical Notified Body AB
Cardia International A/S
Manufacturer
🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
GASTROSTOMY, TUBES AND SETS
Device
EU MDR
·
Eu Md Class 2b
·Innoventa Medica ApS·On the market·15 countries
GASTROSTOMY, TUBES AND SETS
Device
EU MDR
·
Eu Md Class 2b
·Innoventa Medica ApS·On the market·15 countries
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
Lecigon PEG, ENFit
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·Innoventa Medica ApS·2 devices
CT 5000 change table, 700 x 1200 mm , white. With safety rail and body belt, foldable, fixed height, wall-mounted
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Pressalit A/S·1 device
68620146168
Certificate
MDR Technical Documentation·Innoventa Medica ApS·Intertek Medical Notified Body AB
28620145188
Certificate
MDR QMS·Innoventa Medica ApS·Intertek Medical Notified Body AB
28620146168
Certificate
MDR Technical Documentation·Innoventa Medica ApS·Intertek Medical Notified Body AB·1 Basic UDI-DI
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
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
FDA Enforcement
Class II
·Terminated·B-K Medical A/S·August 10, 2016