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Esaote MYLAB™SEVEN Ultrasound System - HSA Registration DE0015202

Access comprehensive regulatory information for Esaote MYLAB™SEVEN 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 DE0015202 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.

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CLASS B
DE0015202
Esaote MYLAB™SEVEN Ultrasound System
HSA Registration Number: DE0015202
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Product Description

The device is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including: Cardiac Transesophageal Cardiac Peripheral Vascular Neonatal Cephalic Adult Cephalic Small organs Musculoskeletal (Conventional and Superficial) Abdominal Fetal Transvaginal Transrectal Pediatritic and Other: Urologic The 6400 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0015202
Registration Date
April 17, 2014
Change Notification Approval Date
October 29, 2019
Retention Due Date
April 16, 2026
Product Owner
Short Name
Esaote
Address
Via Di Caciolle, 15, 50127 Firenze, ITALY
Registrant
Address
1090 LOWER DELTA ROAD, #05-15/16, SINGAPORE 169201
Importer
Address
1090 LOWER DELTA ROAD, #05-15/16, SINGAPORE 169201 8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Model Information
Model Name(s)
MyLabSeven ECOTOMOGRAPH IH 6-18 Wideband Electronic Linear Array TLC 3-13 Biplane Wideband Electronic Linear-Convex Array LP 4-13 Wideband Electronic Linear Array IL 4-13 Wideband Electronic Linear Array SE 3123 Endocavitary probe 8-4 Mhz R 10mm EC1123 End-Fire 10R Cavity Probe 9 5 BE1123 Biscan Volumetric Endocavitaly probe SL 1543 Linear probe 13-4 SP 2430 PA Adult Cardiology Probe - Ziff Socket AL 2442 Linear Vascular Probe - Ziff socket AC2541 Convex Abdominal Probe - Ziff Socket SP2442 Paediatric Probe ST2612 Transesophageal Probe S2MCW Doppler Probe 2MHz S5MCW Doppler Probe 5MHz SHFCW Doppler Probe HF SB2C41 - BI-Scan Convex Probe 6-1,5 - Ziff Socket IOT 342 Probe - Ziff Socket SI2C41 Wideband Electronic Convex Array SL2325 Linear probe, 02.2 SL3116 Wideband Electronic Linea Array SC3123 Convex Probe 10-6 - Ziff Socket 6400 Battery pack Needle Visibility Cardio Licence Vascular Licence General Imaging Licence OB/Gyn Licence Stress Licence Dicom Licence Doppler Licence CFM Licence TVM Licence CnTI Licence 3D/4D Licence CMM Licence M-View Licence XStrain Licence QIMT Licence VPan Licence Quality Arterial Stiffness QAS 3D/4D XLIGHT Rendering Respirometer or Breathing Curve Elaxto measurement Rheuma Library code Rheuma Library viewer LVO (Left Ventricle Opacification) Rheuma Library Preview LA523 Linear Probe 13-4 BC431 B-Scan Volumetric Convex Probe 6-1.5
Model Identifier(s)
101640000 120000023 120000025 120000026 120000027 121000700 121010000 121010800 121012300 121200100 121200300 121200500 121200600 121200800 121201000 121201100 121201200 121201500 121201600 121201800 121202000 122000100 122000500 141004100 301000081 301000900 301000901 301000902 301000904 301000907 301000909 301000910 301000911 301000912 301000915 301000916 301000920 301000926 301000929 301000937 301001013 301001035 301001082 301001083 301001084 301001090 301001091 301001094 301001095 9600156000 9600183000