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