Rontis Corporation SA

Manufacturer

🇨🇭 Switzerland·225 Basic UDI-DIs·443 Devices·TÜV NORD CERT GmbH, TÜV NORD CERT GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, and TUV NORD Polska Sp. z o.o

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

E.histolytica Antibody 96Tests

FDA UDI

SCIMEDX CORPORATION·00813545025397·

E.histolytica Antibody 96 Test with Calibrator

FDA UDI

SCIMEDX CORPORATION·00813545025403·

Triage

FDA UDI

QUIDEL CARDIOVASCULAR INC.·30014613337928·Triage Cardiac Panel (OUS)

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

ASFORA BULLET CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR

FDA 510(k)

FDA Class 1 ·Microbiology

ASFORA BULLET CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

TAMCENAN OCULAR EXPLANTS AND BANDS

FDA 510(k)

FDA Class 2 ·Ophthalmic

RAMCLEAN DENTAL VACUUM LINE CLEANER

FDA 510(k)

FDA Class 1 ·Dental

MUELLER HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

RESTRAINING STRETCHER

FDA 510(k)

FDA Class 1 ·General Hospital

Portare System (FA-001)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SELENITE F BROTH

FDA 510(k)

FDA Class 1 ·Microbiology

ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM

FDA 510(k)

FDA Class 2 ·Orthopedic

HAND DRILL, MODEL 11-9901-7

FDA 510(k)

FDA Class 2 ·Neurology

SICAGE™ System

FDA 510(k)

FDA Class 2 ·Orthopedic

MASTEL LASER CLEAN ROOM, MODEL EBS-100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery