Certificate Number: MD 670368
Scope: The design, development, manufacture and distribution 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, Radiology, Endoscopy, Biliary, General Surgery (including Minimally Invasive Surgical Procedures), and Embolic Protection. Manufacture activities associated with radio frequency and cryo ablation devices and accessories. Products include: Biliary stents, cardiovascular stents, ureteral stents, pancreatic stents; drug eluting stents and delivery catheter systems; balloon catheters, angiographic catheters, microcatheters, drainage catheters, introducer catheters, urological catheters, percutaneous catheters, ablation catheters, and guide catheters; biliary devices, surgical mesh, electrosurgical instruments and generators, software for generators, retrieval devices, feeding devices, cannulas, electrodes, endoscopes, examination gloves, irrigation/drainage devices and sets, Fluid circulations pumps, fluid administration, filling and infusion devices, inflators, ligators, dilators, connecting tubes, access sheaths, tubing sets; adaptors; left atrial appendage (LAA) closure devices and accessory devices; percutaneous access needles, aspiration needles, injection needles, introducer needles, endotherapy electrode system, fiber optic laser delivery devices; radiofrequency and cryo ablation system, systems and accessory devices; sutures and suturing devices, syringes, vascular introducers, nephrostomy devices, guidewires, biopsy devices, polypectomy devices, hemostasis devices, torque devices, cuff kits, endoscopic valves, endoscope channel support kits, biopsy caps, locking devices, bladder evacuators, sphincterotomes, embolic protection systems, and embolization devices, ultrasound imaging catheters, retrieval sheaths, diagnostic software and recording systems, diagnostic mapping, pacing and recording catheters inclusive of accessory devices, pericardiocentesis kits; cables. Minimally invasive tissue and thrombus removal devices, atherectomy angioplasty devices, electrophysiology recording and mapping systems, including refurbishment, and software inclusive of accessory devices.
External instrumentation for implantable cardiac monitors, implantable cardiac pulse generators and implantable cardioverter defibrillators including implantable cardiac pacing and defibrillation leads. Design, development, manufacture, and sterilization of penile prosthesis and associated accessories, implants for incontinence and associated accessories and surgical tools. Manufacture of medical laser systems and accessories.
Manufacture and service of medical device electronic systems associated with diagnostics, monitoring and therapy.
Manufacture, distribution, and service of ultrasound imaging systems inclusive of accessory devices.
The installation of peripheral intervention systems (including minimally invasive tissue and thrombus removal devices) and ultrasound imaging systems and service (software upgrades and updates) of capital equipment.
Manufacture medical device components and subassemblies for gastrointestinal, endoscopy and biliary medical devices.
Design & manufacture of implantable silicone obesity devices.
In house ethylene oxide sterilization in accordance with EN ISO 11135:2014.
