AOTI Limited

Manufacturer

🇮🇪 Ireland

Hyperbox System

FDA UDI

AOTI LIMITED·05391518749990·The Hyper-Box Homecare System is intended to be...

Hyperbox System

FDA UDI

AOTI LIMITED·05391518740027·The Hyper-Box Topical Wound Oxygen System is in...

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS

Disposable Anesthesia Circuit

FDA UDI

WESTMED, INC.·00709078006029·Anesthesia Circuit, Adult, 72", GSE w/CAP Swive...

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR MUTATION TEST v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

Advena Limited

Authorized representative

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Caretechion GmbH

Authorized representative

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Cleverstore.ro Srl

Importer

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MedPath GmbH

Authorized representative

🇩🇪 Germany·537 Manufacturers·13464 Devices