BEUDAMED
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    Zimmer Biomet Canada DFE

    FDA registration
    Zimmer Biomet Canada DFE·20 products·🇨🇦 Canada

    Zimmer CAS

    Manufacturer
    🇨🇦 Canada·1 Importer

    OCULAR BIOMETER 4000

    FDA 510(k)

    ABK BIOMEDICAL

    FDA registration
    ABK BIOMEDICAL·1 product·🇨🇦 Canada

    Response Biomedical Corp.

    FDA registration
    Response Biomedical Corp.·7 products·🇨🇦 Canada

    HALIFAX BIOMEDICAL INC.

    FDA registration
    HALIFAX BIOMEDICAL INC.·5 products·🇨🇦 Canada

    BIO-MATE PIC CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIO-MATE(TM) EPIDURAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RAMP 200

    Device
    EU IVDR · Eu Ivd Class A ·Response Biomedical Corp.·On the market·2 countries

    Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.

    FDA Enforcement
    Class II ·Terminated·Response Biomedical Corp.·March 18, 2020

    RAMP 200 Instrument

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Response Biomedical Corp.·1 device