Singapore - English - HSA (Health Sciences Authority)

samsung electronics singapore pte. ltd. - general hospital - the blood pressure app (bp app) is a software-only, mobile medical application intended for use with a compatible samsung galaxy watch and phone to create, record, store and display blood pressure information. the bp app determines the systolic and diastolic blood pressure, as well as pulse rate, and provides values and history charts following calibration with a upper-arm, cuff-based blood pressure monitor. the bp app is intended for over-the-counter (otc) use in adults 22 years and older. it may not provide accurate results in pregnant women. this information can be used as an indication for trends in blood pressure between regular checks by healthcare professional. the user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional and validation with a standard measurement method. the bp app is not intended to replace traditional methods for diagnosis or treatment of hypertension.

Singapore - English - HSA (Health Sciences Authority)

samsung electronics singapore pte. ltd. - cardiovascular - the samsung ecg application is an over-the-counter (otc) software-only, mobile medical application operating on a compatible samsung galaxy watch and phone. the app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ecg), similar to a lead i ecg for adults 22 years and older. classifiable traces are labeled by the app as either atrial fibrillation (afib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. the app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. the ecg and rhythm classification may be used by users with or without known af as data that may be shared with a qualified healthcare professional.

Singapore - English - HSA (Health Sciences Authority)

samsung electronics singapore pte. ltd. - cardiovascular - the blood pressure app (bp app) is a software-only, mobile medical application intended for use with a compatible samsung galaxy watch and phone to create, record, store and display blood pressure information. the bp app determines the systolic and diastolic blood pressure, as well as pulse rate, and provides values and history charts following calibration with a upper-arm, cuff-based blood pressure monitor. the bp app is intended for over-the-counter (otc) use in adults 22 years and older. it may not provide accurate results in pregnant women. this information can be used as an indication for trends in blood pressure between regular checks by healthcare professional. the user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional and validation with a standard measurement method. the bp app is not intended to replace traditional methods for diagnosis or treatment of hypertension.

Singapore - English - HSA (Health Sciences Authority)

samsung electronics singapore pte. ltd. - cardiovascular - the samsung ecg application is an over-the-counter (otc) software-only, mobile medical application operating on a compatible samsung galaxy watch and phone. the app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ecg), similar to a lead i ecg for adults 22 years and older. classifiable traces are labeled by the app as either atrial fibrillation (afib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. the app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. the ecg and rhythm classification may be used by users with or without known af as data that may be shared with a qualified healthcare professional.

Singapore - English - HSA (Health Sciences Authority)

i med asia pte. ltd. - hematology - the samsung labgeo hc10 is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use of whole blood specimens, developed for clinical laboratories.

Singapore - English - HSA (Health Sciences Authority)

i med asia pte. ltd. - immunology - the samsung labgeo ib cardiac 3-in-1 panel test is a rapid point-of-care (poc) immunoassay for the in vitro quantitative determination of cardiac troponin i (ctni), ck-mb and myoglobin, in lithium heparin whole blood and plasma. this test is intended for use in conjunction with the samsung labgeo ib10 analyzer

Singapore - English - HSA (Health Sciences Authority)

i med asia pte. ltd. - clinical chemistry - the samsung labgeo ib chf plus test is a rapid point-of-care (poc) immunoassay for the in vitro quantitative determination of cardiac troponin i (ctni) and n-terminal pro-brain natriuretic peptide (nt-probnp) in lithium heparin human whole blood and plasma. the chf plus test is intended for use in conjunction with the samsung labgeo ib10 analyzer

Singapore - English - HSA (Health Sciences Authority)

i med asia pte. ltd. - clinical chemistry - the samsung labgeopt hepatic test 9, used with the samsung labgeo pt10, is intended to be used for the in vitro quantitative determination of albumin(alb), alanine aminotransferase(alt), aspartate aminotransferase(ast), alkaline phosphatise(alp), ϒ-glutamyl transpeptidase(ggt), glucose(glu), total bilirubin(tbil), direct bilirubin(dbil), and total protein(tp) in serum, plasma, lithium-heparinized whole blood.

Singapore - English - HSA (Health Sciences Authority)

i med asia pte. ltd. - clinical chemistry - the samsung labgeo pt lipid test 5, used with the samsung labgeo pt10, is intended to be used for the in vitro quantitative determination of glucose(glu), total cholesterol(chol), triglyceride(trig), and high density lipoprotein cholesterol(hdl) in serum, plasma, lithium-heparinized whole blood. the low density lipoprotein cholesterol (ldl) is calculated with this measurement.

Singapore - English - HSA (Health Sciences Authority)

quest asia technologies pte ltd - obstetrics & gynaecology - the ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyse body fluids. the clinical applications include: fetal/ obstetrics, abdominal, gynecology, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, muscular-skeletal (conventional, superficial), urology, cardiac, adult, cardiac pediatric and peripheral vessel.