Esaote MYLAB™TWICE Ultrasound System - HSA Registration DE0015200
Access comprehensive regulatory information for Esaote MYLAB™TWICE Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0015200 and owned by Esaote S.p.a.. The device was registered on April 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.
The device is a mainframe ultrasound system used to perform diagnostic general ultarsound studies including, Cardiac Transesophageal Peripheral Vascular Neonatal Cephalic Adult Cephalic Small organ Musculoskeletal (Conventional and Superficial) Fetal Transvaginal Transrectal Pediatritic Intraoperative (Abdominal) Laparoscopic and Other: Urologic The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The Virtual Navigator is a MyLab optional license that provided additional image information from a second modality like CT or MR, during clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following applications: Abdominal, Musculo-skeletal, Urologic and Vascular. The second modality is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information. The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.