4,141 results · 37ms · Sources: EU EUDAMED, US FDA

Nettle

Device
EU MDR · Eu Md Class 2a ·Samphire Neuroscience Ltd·On the market·15 countries

Monitor, U.V., Glc

FDA classification
FDA Class 1 ·Monitor, U.V., Glc

Coating, Liquid, Glc

FDA classification
FDA Class 1 ·Coating, Liquid, Glc

Column Supports, Glc

FDA classification
FDA Class 1 ·Column Supports, Glc

PHC Europe B.V.

Authorized representative
🇳🇱 Netherlands·3 Manufacturers·12 Devices

Titrimetric Permanganate And Bromophenol Blue, Calcium

FDA classification
FDA Class 2 ·Titrimetric Permanganate And Bromophenol Blue, Calcium

System, Test, Systemic Lupus Erythematosus

FDA classification
FDA Class 2 ·System, Test, Systemic Lupus Erythematosus

PATHFAST SAMPLE DILUENT 1

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·PHC Corporation·1 device

PATHFAST SAMPLE DILUENT 2

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·PHC Corporation·1 device

PATHFAST SAMPLE DILUENT 3

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·PHC Corporation·1 device

Incubator

Basic UDI-DI
EU MDR · Eu Md Class 1 ·PHC Corporation·1 device

PATHFAST

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·PHC Corporation·3 devices

Injection Device

Basic UDI-DI
EU MDR · Eu Md Class 2a ·PHC Corporation In Vitro Diagnostics Division·5 devices

System, Test, Her-2/Neu, Ihc

FDA classification
FDA Class 3 ·System, Test, Her-2/Neu, Ihc

Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

FDA classification
FDA Class 1 ·Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

Cooling Gel

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Geocos B.V.·1 device

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification
FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

FDA classification
FDA Class 2 ·System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

V1 091763 0015

Certificate
IVDD Annex IV (excluding sections 4, 6)·GC MEDIS Corp.·TÜV SÜD Product Service GmbH·18 Basic UDI-DIs

V74 091763 0019

Certificate
IVDD Annex IV (excluding sections 4, 6)·GC MEDIS Corp.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI