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Verathon BladderScan i10™ System - HSA Registration DE0506505

Access comprehensive regulatory information for Verathon BladderScan i10™ 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 DE0506505 and owned by Verathon Inc. The device was registered on December 22, 2021.

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
DE0506505
Verathon BladderScan i10™ System
HSA Registration Number: DE0506505
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Product Description

The BladderScan i10™ System is an ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0506505
Registration Date
December 22, 2021
Change Notification Approval Date
March 06, 2025
Retention Due Date
December 21, 2025
Product Owner
Short Name
Verathon Inc
Address
20001 North Creek Parkway, Bothell, WA 98011, WA, UNITED STATES
Registrant
Address
11 LORONG 3 TOA PAYOH, BLOCK B JACKSON SQUARE, #01-13, SINGAPORE 319579
Importer
Address
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model Information
Model Name(s)
BladderScan i10™ System, International Lithium-ion Rechargeable Battery Smart Battery Charger Lithium-ion Rechargeable Battery BladderScan i10™ Console BladderScan i10™ Probe Calibration Tank Kit BladderScan i10™ Workstation Printer, Thermal, BladderScan i10 BladderScan i10™ Printer Kit
Model Identifier(s)
0270-1015 0400-0155 0400-0157 0400-0164 0570-0412 0570-0413 0620-1083 0800-0631 0800-0632 0800-0640