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Esaote MYLAB™25 GOLD Ultrasound System - HSA Registration DE0015220

Access comprehensive regulatory information for Esaote MYLAB™25 GOLD 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 DE0015220 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
DE0015220
Esaote MYLAB™25 GOLD Ultrasound System
HSA Registration Number: DE0015220
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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 Intraoperative (Abdominal) Laparoscopic Other: Urologic The 7340 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
DE0015220
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)
EC1123 End-Fire 10R Cavity Probe 9 5 CA1421 Convex probe 5-2 CA541 Convex Probe BC441 BI-SCAN Convex 6-1,5 probe Cardio Licence Vascular Licence Ob-Gyn Licence Urology Licence Stress Echo Licence Dicom Licence Doppler Licence CFM Licence (to be ordered with Doppler Licence) TVM Licence VPAN Licence CnTi Licence 3D/4D Licence Compass M-Mode Licence X Strain Licence for MyLab 25/30 Gold + USB key Fetal Weight Index Licence (Ob/Gyn Licence is mandatory) QIMT Licence (To be ordered with Vascular Licence) X-Strain Licence only SCP licence Auto Ejection Fraction licence 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 ABS33 (biopsy kit for TRT33) Shorter height support for doking station trolley Internal Battery kit (Contains two battery packs) WBSL33X - (biopsy kit 35 ^) for LA332 2.0 MHz Probe (CW) 5.0 MHz Probe (CW) PA121E Phased Array Probe 2 6 PA122E Phased Array Probe 3 8 PA023E Phased Array Probe 4 11 LA523 Linear Probe 13-4 EC123 End-Fire 10R Cavity Probe 9-4 CA123 14R Microconvex Probe 9-5 IOE323 Intraoperative probe 13 4 LP323 Laparoscopic probe 13-4 PA230E Phased Array Probe 1 4 LA532E linear probe 9-2 CA430E Convex Probe 8 1 TEE022 Multi-plane Transesophageal Probe 7 3 (Nota 1) LA435 Linear Probe 18-6 TRT33 biplane probe 13 3 CA431 Convex Probe 8 1 BC431 B-Scan Volumetric Convex Probe 6-1.5 CA631 - Convex probe 8-1 TEE132 Paediatric Multi-plane Transesophageal Probe ** 7 3 LA 332 Linear iQ-appleprobe BL433 B-Scan Volumetric Linear iQ-appleprobe PA240 Phased Array iQProbe HF Doppler probe ECG Cable IEC ECG Cable AHA Height Adjustable trolley Collapsable trolley Docking station trolley 200-230 V Docking station trolley 100-115 V MyLab25 Gold 100-240V/50-60Hz & Battery
Model Identifier(s)
121010000 121010200 121010900 121011000 8610369000 8610369001 8610369004 8610369005 8610369007 8610369009 8610369010 8610369011 8610369012 8610369013 8610369015 8610369016 8610369020 8610369029 8610369033 8610369037 8610369046 8610369055 8610369058 9101699000 9102156000 9102157000 9102158000 9102159000 9102199000 9102756100 9102868000 9103286000 9103346000 9103525000 9600125000 9600126000 9600151000 9600152000 9600153000 9600156000 9600157000 9600158000 9600160000 9600162000 9600165000 9600168000 9600169000 9600170000 9600173000 9600175000 9600177000 9600183000 9600185000 9600186100 9600190000 9600195000 9600196000 9600214000 9630028000 9630028010 9707315000 9707320010 9807310000 9807310001 9807340002