AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD

FDA 510(k)

FDA Class 2 ·Anesthesiology

PYLORISET EIA-G (68926)

FDA 510(k)

FDA Class 1 ·Microbiology

ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

FDA 510(k)

FDA Class 2 ·Immunology

Orthopantomograph™ OP 3D LX

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED CHLAMYSET ANTIGEN

FDA 510(k)

FDA Class 1 ·Microbiology

DIGORA OPTIME (OR DIGORA ONTIME)

FDA 510(k)

FDA Class 2 ·Dental

BonAlive Granules

FDA 510(k)

FDA Class 2 ·Orthopedic

HAAG-STREIT FUNDUS MODULE 300

FDA 510(k)

FDA Class 2 ·Ophthalmic

AS/3 PRESSURE TEMPERATURE MODULE, M-PT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nexstim Navigated Brain Therapy (NBT) System 2

FDA 510(k)

FDA Class 2 ·Neurology

DELTA 16

FDA 510(k)

FDA Class 2 ·Radiology

THERMOFX MESH

FDA 510(k)

FDA Class 2 ·Dental

GIOVANNI OGNA E FIGLI SRL

Importer

🇮🇹 Italy

FBI Medizintechnik GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

Time-of-Flight Mass Spectrometer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

Automatic Chemiluminescence Immunoassay Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

Automatic Chemiluminescence Immunoassay Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

VID82-

Basic UDI-DI

EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device

Latvia MGI Tech SIA

Authorized representative

🇱🇻 Latvia·1 Manufacturer

Radioimmunoassay, Estriol

FDA classification

FDA Class 1 ·Radioimmunoassay, Estriol