446 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Canada
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AQUANET, MODEL EC 2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018
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
Reveal Rapid HIV Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·1 device
Reveal Rapid HIV Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·1 device
Reveal Rapid HIV Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·1 device
Multiplo Rapid TP/HIV Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·1 device
Multiplo Rapid TP/HIV Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·1 device
Multiplo Rapid TP/HIV Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·1 device
2005 12 0495 CT
Certificate
IVDD Annex IV (excluding sections 4, 6)·MedMira Laboratories Inc.·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS·6 Basic UDI-DIs
Overlay
Device
EU MDR
·
Eu Md Class 1
·Ethnocare Inc.·On the market·32 countries
Overlay
Device
EU MDR
·
Eu Md Class 1
·Ethnocare Inc.·On the market·32 countries