Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN FOR THE TLI SYSTEM

Sunoptic Technologies

FDA UDI

SUNOPTIC TECHNOLOGIES LLC·M678TX0·Tx series Xenon Lightsource

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

TEMO MEDICAL

Importer

🇫🇷 France·6 Manufacturers

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT GS IMAGING SYSTEM

NATECH

Importer

🇫🇷 France·11 Manufacturers

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)

A.M.I. - Analytical Medical Instruments, s.r.o.

Importer

🇨🇿 Czechia·19 Manufacturers

S. A. B. Impex, s.r.o.

Importer

🇨🇿 Czechia·18 Manufacturers

ProCare Ltd.

Importer

🇲🇹 Malta·24 Manufacturers

Eunitor GmbH

Authorized representative

🇩🇪 Germany·83 Manufacturers·896 Devices

Duomed Belgium NV

Importer

🇧🇪 Belgium·62 Manufacturers

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices