BEUDAMED
    2,477 results · 45ms · Sources: EU EUDAMED, US FDA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-EBK-PLUS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-CORE-IGMK PLUS ASSAY

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Free Thyroxine (CLIA), Free T4 Calibrators

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

    Zimmerman/Norymberski, 17-Ketogenic Steroids

    FDA classification
    FDA Class 1 ·Zimmerman/Norymberski, 17-Ketogenic Steroids

    Tube, Smoke Removal, Endoscopic

    FDA classification
    FDA Class 1 ·Tube, Smoke Removal, Endoscopic

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Genesis Neurostimulation System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·ANIMAS VIBE SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay

    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

    FDA classification
    FDA Class 2 ·Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

    24 0237 QR/NB

    Certificate
    MDR QMS·VINAMET CZ s.r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

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

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Hepatitis B e Antigen (HBeAg)

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX INJECTABLE GEL

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·RAPID FFN FOR THE TLI SYSTEM

    Galdent CZ s.r.o.

    Authorized representative
    🇨🇿 Czechia·1 Manufacturer

    2021-MDD/QS-022

    Certificate
    MDD Annex II (excluding section 4)·OR-CZ spol. s r.o.·3EC International a.s.·1 Basic UDI-DI

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID BRAF KIT

    BORGY CZ, a.s.

    Importer
    🇨🇿 Czechia