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Esaote MYLAB™ALPHA Ultrasound System - HSA Registration DE0015203

Access comprehensive regulatory information for Esaote MYLAB™ALPHA 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 DE0015203 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
DE0015203
Esaote MYLAB™ALPHA Ultrasound System
HSA Registration Number: DE0015203
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Product Description

The device is a compact 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 7400 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
DE0015203
Registration Date
April 17, 2014
Change Notification Approval Date
October 29, 2019
Retention Due Date
April 16, 2026
Product Owner
Short Name
Esaote S.p.A.
Address
Via Siffredi 58, 16153 Genova - ITALY, 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)
MyLabAlpha 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 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 PA Pediatric Probe - Ziff Socket S2MCW Doppler Probe 2MHz S5MCW Doppler Probe 5MHz SHFCW Doppler Probe HF IOT 342 Probe - Ziff Socket SI2C41 Wideband Electronic Convex Array SL2325 Linear probe - Ziff Socket SL3116 Wideband Electronic Linear Array SC3123 Convex Probe 10-6 - Ziff Socket Battery pack MyLabAlpha Roll Stand MyLabAlpha Foldable trolley MyLabAlpha and accessory holder and cover Needle Visibility Cardio Licence Vascular Licence General Imaging Licence Ob/Gyn Licence Stress Echo Licence Dicom Licence Doppler Licence CFM Licence TVM Licence VPan Licence Cnti Licence 3D-4D Licence baby face CMM Licence M-View Licence X-Strain Licence Quality Arterial Stiffness QAS QIMT Licence 3D/4D XLIGHT Rendering Respirometer or Breathing Curve Elaxto measurement Rheuma Library code Rheuma Library viewer LVO (Left Ventricle Opacification) Rheuma Library Preview
Model Identifier(s)
101740000 120000023 120000025 120000026 120000027 121000700 121012300 121200100 121200300 121200500 121200600 121201000 121201100 121201200 121201600 121201800 121202000 122000100 122000500 141005700 151001800 221007000 221007100 301000081 301001000 301001001 301001002 301001004 301001007 301001009 301001010 301001011 301001012 301001013 301001015 301001016 301001020 301001026 301001029 301001035 301001037 301001082 301001083 301001084 301001090 301001091 301001094 301001095