145 results · 28ms · Sources: EU EUDAMED, US FDA

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GenomeMe Lab Inc.

Manufacturer
🇨🇦 Canada·2 Importers

O-Two Medical Technologies Inc.

Manufacturer
🇨🇦 Canada·1 Importer

MedMira Laboratories Inc.

Manufacturer
🇨🇦 Canada·6 Basic UDI-DIs·6 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

Artron Laboratories Inc.

Manufacturer
🇨🇦 Canada·1 Importer

MetaOptima Technology Inc.

Manufacturer
🇨🇦 Canada·1 Importer

bioLytical Laboratories Inc.

Manufacturer
🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S

DNA Genotek Inc.

Manufacturer
🇨🇦 Canada·10 Basic UDI-DIs·31 Devices·5 Importers

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

FDA Enforcement
Class I ·Ongoing·Red Medical Supplies·October 20, 2021

EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU

FDA Enforcement
Class I ·Ongoing·Red Medical Supplies·October 20, 2021

EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

FDA Enforcement
Class I ·Ongoing·Red Medical Supplies·October 20, 2021

Reveal Rapid HIV Test

Device
EU IVDD · Eu Ivd Annex 2 List A ·MedMira Laboratories Inc.·On the market

Reveal Rapid HIV Test

Device
EU IVDD · Eu Ivd Annex 2 List A ·MedMira Laboratories Inc.·On the market

Reveal Rapid HIV Test

Device
EU IVDD · Eu Ivd Annex 2 List A ·MedMira Laboratories Inc.·On the market

Multiplo Rapid TP/HIV Test

Device
EU IVDD · Eu Ivd Annex 2 List A ·MedMira Laboratories Inc.·On the market

Multiplo Rapid TP/HIV Test

Device
EU IVDD · Eu Ivd Annex 2 List A ·MedMira Laboratories Inc.·On the market

Multiple Rapid TP/HIV Test

Device
EU IVDD · Eu Ivd Annex 2 List A ·MedMira Laboratories Inc.·On the market

INSTI HIV Self Test

Device
EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Device
EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 Antibody Test

Device
EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

iSTATIS COVID-19 Ag HOME TEST

Device
EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries