No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

CMV MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

APTT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

LIQUID CHROMATO. COLUMNS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

COE PAK AUTO MIX, REGULAR OR HARD SET

FDA 510(k)

FDA Class 2 ·Dental

DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

FDA 510(k)

FDA Class 2 ·Microbiology

PROTEIN S CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

BIOBRANE(R) II

FDA 510(k)

FDA Unclassified ·Unknown

GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILK'N FX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POREX(TM) PROSTHESIS, CHIN, INTERNAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER

FDA 510(k)

FDA Class 2 ·General Hospital

PL 20/20 INFANT VISION TESTER

FDA 510(k)

FDA Class 1 ·Ophthalmic

MODIFICATION TO: VELSCOPE

FDA 510(k)

FDA Class 2 ·Dental

ORTHO* RUBELLA-G ANTIBODY ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL FT-100 INTRACRANIAL PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

BT-1 INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital