486 results
·
7ms
·
Sources: EU EUDAMED, US FDA
QMIA
Device
EU IVDD
·
Eu Ivd General
·QuantaMatrix Inc.·No longer on the market
QPLEX
Device
EU IVDD
·
Eu Ivd General
·QuantaMatrix Inc.·No longer on the market
QMAC-dRAST
Device
EU IVDD
·
Eu Ivd General
·QuantaMatrix Inc.·On the market
dRAST
Device
EU IVDR
·
Eu Ivd Class A
·QuantaMatrix Inc.·On the market
Augma Shield (Mode: OB23)
Device
EU MDR
·
Eu Md Class 1
·TBM Corporation·On the market·3 countries
Ora-Aid (Model: OB53)
Device
EU MDR
·
Eu Md Class 1
·TBM Corporation·On the market·2 countries
Ora-Aid
Device
EU MDR
·
Eu Md Class 1
·TBM Corporation·On the market·10 countries
170775883
Certificate
MDD Annex II (excluding section 4)·Navbit Pty Ltd·DQS Medizinprodukte GmbH·1 Basic UDI-DI
541616 MR2
Certificate
MDD Annex II (excluding section 4)·Navbit Pty Ltd·DQS Medizinprodukte GmbH·1 Basic UDI-DI
ES19/86843
Certificate
MDD Annex II (excluding section 4)·Xavant Technology (Pty) Ltd·SGS Belgium NV·3 Basic UDI-DIs
QMIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·QuantaMatrix Inc.·1 device
QPLEX™ COVID-19 Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·QuantaMatrix Inc.·1 device
QMAC-dRAST GN S17, QMAC-dRAST GP S17, QMAC-dRAST GN E19, QMAC-dRAST GP E19, QMAC-dRAST GN E22
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·QuantaMatrix Inc.·1 device
dRAST
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·QuantaMatrix Inc.·1 device
Ora-Aid
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·TBM Corporation·3 devices
ORAgene (Swab-based DNA & Dx Collection Device)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·4 devices
geneLEAD Waste Box
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Precision System Science Co., Ltd.·1 device
geneLEAD VIII PCR Reaction Cassette Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Precision System Science Co., Ltd.·1 device
geneLEAD VIII PCR Reagent Cassette Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Precision System Science Co., Ltd.·1 device
geneLEAD VIII Consumable Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Precision System Science Co., Ltd.·1 device