Draeger Jaundice Meter JM-105 - HSA Registration DE0016335
Access comprehensive regulatory information for Draeger Jaundice Meter JM-105 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016335 and owned by Draeger Medical Systems, Inc.. The device was registered on September 17, 2014.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Jaundice Meter is non-invasive transcutaeous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants. The Jaundice Meter is indicated for use in neonatal patients born ≥24 weeks gestation who have not undergone exchange transfusion. The device is indicated only for use before, during, and after phototherapy treatment. The device is intended for use in hospitals or doctors offices under a physician's supervision, or at their direction. It helps clinicians to monitor newborn infants. The device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia. It is used as a screening device with other clinical signs and laboratory measurements.