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Esaote MYLAB™40 Ultrasound System - HSA Registration DE0015221

Access comprehensive regulatory information for Esaote MYLAB™40 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 DE0015221 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
DE0015221
Esaote MYLAB™40 Ultrasound System
HSA Registration Number: DE0015221
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Product Description

The device is a compact console 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 and Other: Urologic

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0015221
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)
MyLab40 CA541 probe PA240 probe LCD 19" COLOR MONITOR EIZO EA710 ARTICULATING ARM (for model EA700/EA710) SCP 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 2.0 MHz Probe (CW) 5.0 MHz Probe (CW) Pencil Probe HF CW ECG Cable IEC ECG Cable AHA DBS523 Starter Kit for LA523, A522, LA532 PAL setting Ng Type X, For Ec1123 LCD Attachment set (for all models) EC1123 End-Fire 10R Cavity Probe 9 5 Cardio License Vascular License Ob-Gyn License Urology License Stress Echo License Clips Archiving License DICOM License TVM License V-PAN License CnTi License Compass M-Mode License CA1421 Convex probe 5 2 LCD 17" COLOR MONITOR AY17L1 BE1123 B-scan Volumatric Endo cavity probe 3D-4D & Freehand 3D license (Ob-Gyn License Required) Q IMT license (RF based) (Vascular License Required) Fetal weight index license (Ob-Gyn License Required) 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 BC431 B-scan Volumetric Convex probe CA631 - Convex probe 8-1 LA 332 Linear probe TRT33 biplane probe M-View Licence TEE132 Pediatric Multi-plane Transesophageal Probe 7 3 LCD 19" COLOR MONITOR EIZO EA700
Model Identifier(s)
102276000 122010900  122011400  152001600 152001700 302005000  9101699000 9102156000 9102157000 9102158000 9102159000 9102199000 9102756100 9600125000 9600126000 9600214000 9630028000 9630028010 9650056000 97154311931 97154411057 97154411259 97154411312 97154411360 97154411361 97154411362 97154411363 97154411365 97154411366 97154411367 97154411371 97154411372 97154411373 97154411374 97154411395 97154411400 97154411403 97154411460 97154411463 97154411523 97154411664 97154411665 97154411666 97154411669 97154411670 97154411671 97154411672 97154411673 97154411675 97154411677 97154411678 97154411679 97154411681 97154411682 97154411683 97154411686 97154411696 97154411759 97154411780 97154411806