סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - radiology / imaging - the sim&size software is a medical device intended to provide a 3dview of the final deployment of implants. it uses an actual image of the patient produced by 3d rotational angiography. it offers clinicians the possibility of simulating deployment of implantable medical devices (imd) in the artery to be treated and simulates the final position (length, diameter, form) and the extent of apposition of the implant. sim&size is not intended for diagnostic use or for recommending a specific treatment.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - general hospital - sol-m™ pen needle is intended for use with a pen injector device for subcutaneous injection of insulin.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - gastroenterology & urology - the amt transgastric-jejunal feeding tube is indicated for use in patients who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy. the use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. this includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions. the amt transgastric-jejunal feeding tube is intended for use in adult, adolescent, child, and infant patients over 10kg.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - immunology - guardant360® cdx is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of single nucleotide variants, insertions and deletions in 55 genes, copy number amplifications in two genes,and fusions in four genes. guardant360 cdx utilizes circulating cell-free dna from plasma of peripheral whole blood. the test is intended to be used as a companion diagnostic to identify non-small cell lung cancer patients who may benefit from treatment with tagrisso® (osimertinib) in accordance with the approved therapeutic product labeling. additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm. the test is for use with patients previously diagnosed with cancer and in conjunction with other laboratory and clinical findings.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - gastroenterology & urology - the amt balloon g-tube is to be used as a percutaneous replacement gastrostomy tube for a patient with a well-established gas-trostomy tract. this device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. the amt balloon g-tube can also deliver medication and allow for decompression of the stomach.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - microbiology - allplex™ gi-parasite assay is a qualitative in vitro test for the single or multiple detection of giardia lamblia (gl), entamoeba histolytica (eh), cryptosporidium spp. (cr), blastocystis hominis (bh), dientamoeba fragilis (df) and cyclospora cayetanensis (cc) in human stool specimens from individuals with symptoms of gastroenteritis or infectious diarrhea.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - microbiology - allplex™ vaginitis screening assay is a qualitative and quantitative in vitro test for the single or multiple pathogen detection of lactobacillus spp. (lacto; lactobacillus crispatus, lactobacillus gasseri and lactobacillus jensenii), gardnerella vaginalis (gv), atopobium vaginae (av), mobiluncus spp.(mob; mobiluncus mulieris and mobiluncus curtisii), candida albicans (ca), candida others (co; candida krusei, candida glabrata, candida dubliniensis, candida parapsilosis, candida tropicalis and candida lusitaniae) and trichomonas vaginalis (tv). allplex™ vaginitis screening assay is intended to aid the diagnosis of vaginal infection in women with a clinical symptom consistent with bacterial vaginosis. allplex™ vaginitis screening assay should be interpreted in conjunction with other laboratory clinical data from the physicians.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - general hospital - the sol-care™ safety blood collection needle with pre-attached holder is a single-use, sterile, winged blood collection needle to be used for blood collection. the device is designed with a safety mechanism to help reduce the risk of needlestick injury.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - general hospital - the sol-care™ safety winged infusion set is a sterile winged infusion device with tubing and end cap. the device is used for infusion of intravenous fluids. the device is designed with a safety mechanism to help reduce the risk of needlestick injury.

סינגפור - אנגלית - HSA (Health Sciences Authority)

andaman medical pte. ltd. - gastroenterology & urology - the enteral extension sets are for administering feeding, medications and decompression to compatible devices.