PLASMODIUM (MALARIA) - RT & POC

Device

EU IVDD · Eu Ivd General ·Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.·On the market·13 countries

BRAEBON Medical Corporation

Manufacturer

🇨🇦 Canada·20 Basic UDI-DIs·143 Devices·9 Importers·INTERTEK SEMKO AB and INTERTEK SEMKO AB

Front Line Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·2 Importers·Intertek Medical Notified Body AB and Intertek Medical Notified Body AB

Performance Health International LTD

Manufacturer

2 Basic UDI-DIs·2 Devices·6 Importers·INTERTEK SEMKO AB

Spectra Medical Devices, LLC

Manufacturer

🇺🇸 United States·4 Basic UDI-DIs·4 Devices·INTERTEK SEMKO AB

InGeneron Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·INTERTEK SEMKO AB

Malaria Whole Blood Combo Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.·1 device

Spectra Guide Wire Introducer (GWI) Needle

Device

EU MDD · Eu Md Class 2a ·Spectra Medical Devices, LLC·On the market·5 countries

Spectra Radio Frequency (RF) Needle

Device

EU MDD · Eu Md Class 2a ·Spectra Medical Devices, LLC·On the market·5 countries

Neen

Device

EU MDD · Eu Md Class 2a ·Performance Health International LTD·On the market·1 country

Neen

Device

EU MDD · Eu Md Class 2a ·Performance Health International LTD·On the market·1 country

Spectra Epidural Needle

Device

EU MDD · Eu Md Class 3 ·Spectra Medical Devices, LLC·On the market·5 countries

MediByte Jr

Device

EU MDD · Eu Md Class 2a ·BRAEBON Medical Corporation·On the market·5 countries

MediByte

Device

EU MDD · Eu Md Class 2a ·BRAEBON Medical Corporation·On the market·5 countries

Transpose Ultra

Device

EU MDD · Eu Md Class 1 ·InGeneron Inc.·On the market·2 countries

Spectra Safe-Cut® Safety Scalpel

Device

EU MDD · Eu Md Class 2a ·Spectra Medical Devices, LLC·On the market·5 countries

AORTIC OCCLUSION SYSTEMS

Device

EU MDR · Eu Md Class 3 ·Front Line Medical Technologies Inc.·On the market·12 countries

Spectra Guide Wire Introducer (GWI) Needle

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Spectra Medical Devices, LLC·1 device

Spectra Radio Frequency (RF) Needle

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Spectra Medical Devices, LLC·1 device

MediByte Jr

Basic UDI-DI

EU MDD · Eu Md Class 2a ·BRAEBON Medical Corporation·1 device