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

    Boston Scientific Corporation

    Boston Scientific Corporation
    2546 First Street, Propark
    El Coyol, Alajuela
    Costa Rica
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    Certificate number: MD 670368
    Scope: Manufacture of devices in the areas of Peripheral (including Peripheral Interventions), Cardiovascular (including Cardiovascular Interventions), Electrosurgical Applications (including Electrophysiology), Gastroenterology, Nephrology, Gynecology, Urology, Endoscopy, Biliary, General Surgery (including Minimally Invasive Surgical Procedures) and Embolic Protection. Manufacture activities associated with radio frequency ablation devices and accessories. Products include: biliary stents, ureteral stents, drainage catheters, introducer catheters, urological catheters, percutaneous catheters, biliary devices, ligators, adaptors, percutaneous access needles, injection needles, sutures and suturing devices, nephrostomy devices, guidewires, biopsy devices, polypectomy devices, hemostasis devices, torque devices, sphincterotomes, embolic protection systems, fluid filling devices, ultrasound imaging catheters, electrodes, cannulas, retrieval devices, retrieval sheaths, and endoscopes. Manufacture of intravascular recanalization systems. Manufacture of implantable silicone obesity devices. Manufacture of cardiac ablation catheters. In house ethylene oxide sterilization in accordance with EN ISO 11135:2014.

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

    Certificate number: MDSAP 672104
    Scope: Manufacture of devices in the areas of Peripheral (including Peripheral Interventions), Cardiovascular (including Cardiovascular Interventions), Electrosurgical Applications (including Electrophysiology), Gastroenterology, Nephrology, Gynecology, Urology, Endoscopy, Biliary, General Surgery (including Minimally Invasive Surgical Procedures) and Embolic Protection. Manufacture activities associated with radio frequency ablation devices and accessories. Products include: biliary stents, ureteral stents, drainage catheters, introducer catheters, urological catheters, percutaneous catheters, cardiac ablation catheters, biliary devices, ligators, adaptors, percutaneous access needles, injection needles, sutures and suturing devices, nephrostomy devices, guidewires, biopsy devices, polypectomy devices, hemostasis devices, torque devices, sphincterotomes, embolic protection systems, fluid filling devices, ultrasound imaging catheters, electrodes, cannulas, retrieval devices, retrieval sheaths, and endoscopes. Manufacture of intravascular recanalization systems. Manufacture of implantable silicone obesity devices. The provision of ethylene oxide sterilization of legal manufacturer's medical devices.

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