14 results · 47ms · Sources: EU EUDAMED, US FDA

Sunrise system

FDA registration
SUNRISE SA·1 product·🇧🇪 Belgium

Sunrise Sleep Disorder Diagnostic Aid

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Device For Sleep Apnea Testing Based On Mandibular Movement

FDA classification
FDA Class 2 ·Device For Sleep Apnea Testing Based On Mandibular Movement

KIT COBAS 6800/8800 EBV 192T IVD

FDA registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD.·1 product·🇨🇭 Switzerland

KIT COBAS 6800/8800 EBV 192T IVD

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

Luminopia One

FDA registration
LUMINOPIA INC·1 product·🇺🇸 United States

KIT COBAS 6800/8800 EBV 192T IVD

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

KIT COBAS 6800/8800 EBV 192T IVD

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

OsteoProbe

FDA registration
ACTIVE LIFE SCIENTIFIC, INC.·1 product·🇺🇸 United States

OsteoProbe

FDA registration
BIOSEAL·1 product·🇺🇸 United States

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)
FDA Class 2 ·Microbiology

EEVA 2.0

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

FDA classification
FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

Embryo Image Assessment System, Assisted Reproduction

FDA classification
FDA Class 2 ·Embryo Image Assessment System, Assisted Reproduction