18 results
·
68ms
·
Sources: EU EUDAMED, US FDA
RK GENCELLS
FDA 510(k)
FDA Class 1
·Hematology
HEP-2 GENCELLS
FDA 510(k)
FDA Class 1
·Hematology
HEK GENCELLS
FDA 510(k)
FDA Class 1
·Hematology
MRC-5 GENCELLS
FDA 510(k)
FDA Class 1
·Hematology
MCCOY GENCELLS
FDA 510(k)
FDA Class 1
·Hematology
VERO GENCELLS
FDA 510(k)
FDA Class 1
·Hematology
HSV IDR
FDA 510(k)
FDA Class 2
·Microbiology
WI-38 GENCELLS
FDA 510(k)
FDA Class 1
·Hematology
RMK GENCELLS CULTURE SYSTEM
FDA 510(k)
FDA Class 1
·Hematology
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
FDA registration
Hologic, Inc.·1 product·🇺🇸 United States
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
FDA registration
HOLOGIC, INC.·1 product·🇺🇸 United States
VENUS DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen BRAF V600E RGQ PCR Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen PDGFRA RGQ PCR Kit
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
FDA classification
FDA Class 2
·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
Inherited Nucleotide Repeat Disorder Dna Test
FDA classification
FDA Class 2
·Inherited Nucleotide Repeat Disorder Dna Test
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers