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Esaote MYLAB™FIVE Ultrasound System - HSA Registration DE0015218

Access comprehensive regulatory information for Esaote MYLAB™FIVE 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 DE0015218 and owned by Esaote S.p.a.. The device was registered on April 21, 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
DE0015218
Esaote MYLAB™FIVE Ultrasound System
HSA Registration Number: DE0015218
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Product Description

The device is a compact ultrasound system used to perform diagnostic general ultrasound studies including: Cardiac Transesophageal Peripheral Vascular Neonatal Cephalic Adult Cephalic Small organ Musculoskeletal (Conventional and Superficial) Abdominal Fetal Transvaginal Transrectal Pediatritic Laparoscopic Intraoperative Abdominal and Other: Urologic The 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
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0015218
Registration Date
April 21, 2014
Retention Due Date
April 20, 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
Model Information
Model Name(s)
Troller ABS15 (biopsy angle of 45 deg.) for IOE 323 Probe ABS424 (biopsy angle of 45 deg.) ABS523 (biopsy kit for LA 523) ABS621 (biopsy angle of 25, 35 deg.) ABS421 (biopsy kit for LA421 and CA 430) ABS123 ( biopsy kit FOR EC 123) Double Freeze Footswitch Rechargeable battery pack for collapsable trolley Shorter height support for docking station trolley 2.0 MHz Probe (CW) 5.0 MHz Probe (CW) Pencil Probe HF CW ECG Cable IEC ECG Cable AHA Linear probe stand off DBS523 Starter Kit for LA523, A522, LA532 Height Adjustable trolley Collapsable trolley PAL setting MyLabFive Version EC1123 End-Fire 10R Cavity Probe 9 5 CA1421 Convex probe 5 2 MyLabFive 100-240V/50-60Hz CFM License Vascular License Ob-Gyn License Urology License Stress Echo License (Cardio License required) Clips Archive License DICOM License Cardio License TVM License CnTi License Compass M-Mode License QIMT License (Real time based on RF input), Vascular License required X-View License 2nd Probe Connector License PA121E Phased Array Probe PA122E Phased Array Probe PA023E Phased Array Probe LA523 Linear Probe EC123 END-FIRE CAVITY PROBE 9-5 CA123 14R Microconvex Probe 9 5 IOE323 Intraoperative probe 10 5 LP 323 Laparoscopic probe 10 5 PA230E Phased Array Probe CA 430E Convex Probe 35 50 TEE022 Multi-plane Transesophageal Probe 7 3 LA 435 Linear Probe 18-6 CA 431 Convex Probe 8 1 CA631 - Convex probe 8-1 LA 332 Linear probe Doppler PW License Doppler CW License Fetal Weight Index License (OB-GYN License required) M-View Licence X-Strain license (off line) for MyLab Desk TRT33 biplane probe TEE132 Pediatric Multi-plane Transesophageal Probe 7 3 UPS group 35 minutes autonomy Docking station trolley 200-230 V Docking station trolley 100-115 V
Model Identifier(s)
7900000325 9101699000 9102156000 9102157000 9102158000 9102159000 9102199000 9102756100 9103156000 9103286000 9600125000 9600126000 9600214000 9630028000 9630028010 9650030000 9650056000 9707315000 9707320010 97154311931 97154312958 97154411312 97154411395 97154411410 97154411423 97154411425 97154411426 97154411427 97154411428 97154411429 97154411430 97154411431 97154411432 97154411434 97154411435 97154411436 97154411437 97154411449 97154411664 97154411665 97154411666 97154411669 97154411670 97154411671 97154411672 97154411673 97154411675 97154411677 97154411678 97154411679 97154411681 97154411683 97154411686 97154411690 97154411691 97154411692 97154411694 97154411695 97154411696 97154411780 9730680004 9807310000 9807310001