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    Boston Scientific Technology &

    Boston Scientific Technology &
    Engineering Services Pvt. Ltd.
    3rd Floor, Bestech Business Tower
    Sector 48
    Sohna Road
    Gurgaon
    122 018
    India
    BSI logo

    Certificate number: MD 670368
    Scope: The design and development of devices in the areas of Cardiovascular (including Cardiovascular Interventions), Peripheral (including Peripheral Interventions), Gynecology, Urology and Endoscopy, Neurology (including Neurovascular) and electrosurgical applications (including Electrophysiology) Radiology, Biliary. These products include Introducer sheath and kits, Vascular access catheter, microcatheters, Guide wires, Hemostasis devices, Thrombus catheter devices, Percutaneous access needles, Biopsy Cap and Locking Devices, Micro and Angled Support Catheters, Electrosurgical instruments & generators and device software. Design and development of external instrumentation for implantable cardiac monitors, implantable cardiac pulse generators and implantable cardioverter defibrillators including implantable cardiac pacing and defibrillation leads.

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

    Certificate number: MDSAP 672104
    Scope: The design and development of devices in the areas of Cardiovascular (including Cardiovascular Interventions), Peripheral (including Peripheral Interventions), Gynecology, Urology and Endoscopy, Neurology (including Neurovascular) and Electrosurgical applications (including Electrophysiology) Radiology, Biliary. These products include Introducer sheath and kits, Vascular access catheter, Microcatheters, Guide wires, Hemostasis devices, Thrombus catheter devices, Percutaneous access needles, Electrosurgical instruments & generators and device software, Biopsy Cap and Locking Devices, Micro and Angled Support Catheters product families. Design and Development of external instrumentation for implantable cardiac monitors, implantable cardiac pulse generators and implantable cardioverter defibrillators including implantable cardiac pacing and defibrillation leads.

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