BEUDAMED
    18 results · 49ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Dynex Technologies Inc

    Manufacturer
    🇺🇸 United States·2 Importers

    DYNEX TECHNOLOGIES, INC.

    FDA registration
    DYNEX TECHNOLOGIES, INC.·3 products·🇺🇸 United States

    DYNEX Agility

    FDA UDI
    DYNEX TECHNOLOGIES, INC.·05060456180058·Automated ELISA Processing System with 12 Incub...

    DYNEX DS2

    FDA UDI
    DYNEX TECHNOLOGIES, INC.·05060456180317·DS2 Automated ELISA Processing System

    DIALISA 2MP

    FDA UDI
    DYNEX TECHNOLOGIES, INC.·05060456180348·DIALISA 2MP, DS2 Automated ELISA Processing System

    DYNEX DS2

    FDA UDI
    DYNEX TECHNOLOGIES, INC.·05060456180003·DS2 Automated ELISA Processing System, with Bar...

    DYNEX DSX

    FDA UDI
    DYNEX TECHNOLOGIES, INC.·05060456180287·Automated ELISA Processing System with 0 Incuba...

    DSX

    FDA Adverse Event
    DYNEX TECHNOLOGIES INC·Product code JQW·January 3, 2017

    DYNEX Agility, Agility Analyzer, Model No. 67000

    FDA Recall
    Open, Classified ·Dynex Technologies, Inc.·Product code LXG·July 5, 2020

    Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.

    FDA Recall
    Terminated ·Dynex Technologies, Inc.·Product code JQW·June 11, 2004

    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.

    FDA Recall
    Open, Classified ·Dynex Technologies, Inc.·Product code LXG·July 16, 2025

    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.

    FDA Enforcement
    Class II ·Ongoing·Dynex Technologies, Inc.·August 27, 2025

    DYNEX Agility, Agility Analyzer, Model No. 67000

    FDA Enforcement
    Class II ·Ongoing·Dynex Technologies, Inc.·June 8, 2022

    DYNEX Technologies GmbH

    Importer
    🇩🇪 Germany·1 Manufacturer

    Mikrogen GmbH

    Importer
    🇩🇪 Germany·4 Manufacturers

    Acorn Regulatory Consultancy Services Ltd

    Authorized representative
    🇮🇪 Ireland·16 Manufacturers·10848 Devices

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices