21 results · 23ms · Sources: EU EUDAMED, US FDA

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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