Certificate Number: FM 702022
Scope: Design and development, manufacture and distribution of sterile and non-sterile medical devices including: face masks, gowns, drapes, surgical gloves, isolation bags, procedure trays and packs for clinical and surgical use, enteral feeding and access devices, suction instruments, blood collection tubes, needles and syringes, biomedical electrodes and accessories, operating room support products, examination gloves, ice bags and biofeedback device.
Manufacture and distribution of sterile and non-sterile medical devices including: irrigation instruments and accessories, irrigation trays, wound drainage systems, hydrogel and petrolatum wound dressings, hydrogel membranes, wound treatment systems and accessories, hot and cold therapy products, and probe covers.
Manufacture of sterile and non-sterile medical devices including: dialysis/ vascular catheters and related accessories to facilitate dialysis catheter insertion, stainless steel guidewires, urinary bags, urinary catheters, urine meter foley trays, foley catheter trays, urethral catheter trays, universal catheterization trays, tracheostomy trays, staple removal trays, suction catheter and midstream catch trays, connection tubes, drain bags, cardiothoracic drainage, gastrointestinal and feeding tubes, blood collection sets, specimen containers, vascular compression devices including vascular compression sleeves and lead wires, infusion sets for the area of vascular therapy, urology drainage systems, endotracheal tubes and feeding sets, suction accessories, catheters, wound care and closure devices, and stylet catheters to treat venous reflux.
Manufacture of moulded components for syringes, blood collection, connecting tubes, and probe covers for cardiothoracic, enteral feeding, suction, and gastric devices.
Servicing of thermometers and negative pressure wound therapy devices.
Design and development of infection control apparel, sterilization wraps, respiratory, gastrointestinal management, blood and specimen collection, thermometry, IV access, cardiothoracic care, needles, vascular therapy, urology, OR/Surgical suction, wound care, airway management, incontinence, maternity care, diagnostics, sharps disposal.
