Singapore HSA registration DE0015217
Esaote MYLAB™ONE Ultrasound System
Singapore·CLASS B·Esaote S.p.a.·Registered April 21, 2014Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90181200
Registration information
- Registration Number
- DE0015217
- Registration Date
- April 21, 2014
- Retention Due Date
- April 20, 2026
Product description
The device is an arm-held ultrasound system used to perform diagnostic general ultrasound studies including: Cardiac Peripheral Vascular Neonatal Cephalic Adult Cephalic Small organ Musculoskeletal (Conventional and Superficial) Abdominal Fetal Obstetrics/Gynaecology Transvaginal Transrectal Pediatritic Intraoperative Abdominal 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.
Product Owner
- Name
- Esaote S.p.a.
- 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)
- MyLabOne 100-240V/50-60Hz SL3116 Linear probe 22 - 15 L20mm SL3323 Linear probe 13 - 6 L40mm SC3421 Convex probe 7 - 3 Radius 40 mm SC3123 Convex probe 10 - 6 Radius 14 mm SL3235 Linear probe 18-6 L25mm SE3123 Endocavity probe 8-4 MHz Radius 10mm SC3121 Convex probe 5-2 Radius 13mm CBSC23X biopsy kit for SC3123 Touchscreen Pencil (10x), Additional battery pack Double battery option (second battery included) Installed in Factory Double battery option (second battery included) Customer update Dicom License Patient database license Clips license Doppler license Women's health licence (OB/Gyn License) Vascular Licence Cardio license M-View license Viewer license PA License Double Freeze Footswitch
- Model Identifier(s)
- 10281000X 122000100 122000200 122000400 122000500 122000600 122000700 122000900 141009500 142001000 152000500 152000800 152001300 302000100 302000200 302000400 302000600 302001700 302002100 302002300 302003500 302003800 302007400 9102756100
About this record
Access comprehensive regulatory information for Esaote MYLAB™ONE 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 DE0015217 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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