37 results
·
102ms
·
Sources: EU EUDAMED, US FDA
Rapid Diagnostic Tests
FDA registration
ASSURE TECH LLC·1 product·🇺🇸 United States
OvaMate Fertility Tracker
FDA registration
ASSURE TECH LLC·1 product·🇺🇸 United States
Rapid Diagnostic Tests
FDA registration
ASSURE TECH LLC·2 products·🇺🇸 United States
Rapid Diagnostic Tests
FDA registration
ASSURE TECH LLC·3 products·🇺🇸 United States
Breath Alcohol Test
FDA registration
ASSURE TECH LLC·1 product·🇺🇸 United States
FaStep Early Pregnancy Rapid Test Midstream
FDA registration
ASSURE TECH LLC·1 product·🇺🇸 United States
Rapid Diagnostic Tests
FDA registration
ASSURE TECH LLC·1 product·🇺🇸 United States
Rapid Diagnostic Tests
FDA registration
ASSURE TECH LLC·1 product·🇺🇸 United States
Rapid Diagnostic Tests
FDA registration
ASSURE TECH LLC·1 product·🇺🇸 United States
Rapid Diagnostic Tests
FDA registration
ASSURE TECH LLC·1 product·🇺🇸 United States
AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Medunion S.L.
Authorized representative
🇪🇸 Spain·59 Manufacturers·1472 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices