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    Check company, site and product certificates - Validation and Verification, UK and global companies

    Boston Scientific Corporation

    Boston Scientific Corporation
    302 Parkway
    Global Park
    Heredia
    Costa Rica
    BSI logo

    Certificate number: MD 670368
    Scope: Design, development, manufacture of devices in the areas of Cardiovascular (including Cardiovascular Interventions), Peripheral (including Peripheral Interventions), Electrosurgical Applications (including Electrophysiology), Gastroenterology, Nephrology, Neurology (Including Neurovascular), Gynecology, Urology, Endoscopy, Biliary and General Surgery (including Minimally Invasive Surgical Procedures). These products include Guidewires, Diagnostic mapping, pacing and recording catheters inclusive of accessory devices, and embolic protection systems. Manufacture of cardiac diagnosis, mapping and ablation catheters, guidewires, torque devices for use with atherectomy and minimally invasive tissue and thrombus removal devices; pericardiocentesis kits. Design and development of inflators, hemostasis devices, torque devices, introducer needles, and embolization devices. The Design and development of balloon catheters, Angiographic Catheters, Microcatheters, Ureteral Stents, Drainage Catheters, Urological Catheters, Connecting Tubes, and Introducer Needles

    Standard/Scheme number or name Start Date Expiry Date
    ISO 13485: 2016 2017-05-08 2026-09-01

    Certificate number: MDSAP 672104
    Scope: Design, development, manufacture of devices in the areas of Cardiovascular (including Cardiovascular Interventions), Peripheral (including Peripheral Interventions), Electrosurgical Applications (including Electrophysiology), Gastroenterology, Nephrology, Neurology (Including Neurovascular), Gynecology, Urology, Endoscopy, Biliary and General Surgery (including Minimally Invasive Surgical Procedures). These products include Guidewires, Diagnostic mapping, pacing and recording catheters inclusive of accessory devices, and embolic protection systems. Manufacture of cardiac diagnosis, mapping and ablation catheters, guidewires, torque devices for use with atherectomy and minimally invasive tissue and thrombus removal devices; pericardiocentesis kits. Design and development of inflators, hemostasis devices, torque devices, introducer needles, and embolization devices. The Design and development of Balloon Catheters, Angiographic Catheters, Microcatheters, Ureteral Stents, Drainage Catheters, Urological Catheters, Connecting Tubes, and Introducer Needles.

    Standard/Scheme number or name Start Date Expiry Date
    MDSAP 2018-02-21 2026-09-01