1,077 results
·
9ms
·
Sources: EU EUDAMED, US FDA
MDT Int'l SA
Manufacturer
🇨🇭 Switzerland·7 Basic UDI-DIs·7 Devices·1 Importer·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', DEKRA Certification B.V., and DEKRA Certification B.V.
TRUD
Device
EU MDD
·
Eu Md Class 2a
·MDT Int'l SA·On the market·4 countries
GAF
Device
EU MDD
·
Eu Md Class 3
·MDT Int'l SA·On the market·2 countries
TRUD
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·MDT Int'l SA·1 device
GAF
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·MDT Int'l SA·1 device
QPZ-01910-18
Certificate
MDD Annex V·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
QCT-0176-21
Certificate
MDD Annex II (excluding section 4)·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
ORAgene (Swab-based DNA & Dx Collection Device)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·4 devices
AAV5 NAb Test Specimen Collection Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Precision for Medicine, Inc.·1 device
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Autobio Diagnostics Co., Ltd.·2 devices
ProGRP Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
D-Dimer Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CA 125 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
TG Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Ferritin Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
NSE Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CA 15-3 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CA 72-4 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CA 19-9 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CEA Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device