SentrySuite Product Line 2.3

FDA registration

Jaeger Medical GmbH·3 products·🇩🇪 Germany

Vyntus BODY

FDA registration

Jaeger Medical America Inc.·3 products·🇺🇸 United States

Vyntus BODY

FDA registration

Jaeger Medical GmbH·3 products·🇩🇪 Germany

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM

LensHooke® X QC Slide (For Semen)

Device

EU IVDR · Eu Ivd Class A ·Bonraybio Co., LTD.·On the market

Access SARS-CoV-2 IgG II QC

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

Access sTfR QC (levels 2 & 3)

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

BCM 400CP

FDA 510(k)

FDA Class 2 ·Radiology

BCM-400C

FDA 510(k)

FDA Class 2 ·Radiology

ARC-600

FDA 510(k)

FDA Class 2 ·Radiology

BCM-ARC 105 X-RAY MOBILE UNIT

FDA 510(k)

FDA Class 2 ·Radiology

BCM-600TX

FDA 510(k)

FDA Class 2 ·Radiology

SPINOSCOPE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Sunglasses

FDA registration

ALLIANCE OPTICAL GROUP ULC·1 product·🇨🇦 Canada

ALLIANCE OPTICAL GROUP ULC

FDA registration

ALLIANCE OPTICAL GROUP ULC·1 product·🇨🇦 Canada