Certificate Number: MDSAP 694714
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, IVA seals, 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, 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 cardio-thoracic, enteral feeding, suction, and gastric devices.
Servicing of thermometers and negative pressure wound therapy devices.
Design and development of:
Sterilization wraps; tracheostomy trays; gastrointestinal and feeding tubes; thermometers and probe covers; cardio-thoracic drainage devices; vascular compression devices and sleeves; urology devices and kits including urinary bags, urinary catheters, urine meters, foley/catheterization trays, suction catheters, connection tubes, and drain bags; suction canisters, surgical instruments and accessories; hydrogel and petrolatum wound dressings and related accessories; endotracheal tubes; adult and pediatric absorbent incontinence products; postpartum absorbent products and nursing breast pads; recording signal and electrosurgical return electrode systems including electrodes, lead wires, and accessories; and sharps disposal.
Manufacture of patient monitoring electrodes, sterile fetal spiral electrodes, external defibrillation electrodes, pacing electrodes, transducer positioning belts, neonatal/pediatric IV boards, temperature probe protector, infant eye protection devices and extravasation detection patch.
