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Verathon BladderScan® Prime Plus System - HSA Registration DE0500684

Access comprehensive regulatory information for Verathon BladderScan® Prime Plus 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 DE0500684 and owned by Verathon Inc. The device was registered on September 25, 2017.

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
DE0500684
Verathon BladderScan® Prime Plus System
HSA Registration Number: DE0500684
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Product Description

The BladderScan Prime Plus System is an ultrasound device intended to be used for measuring the urine volume in the bladder non-invasively.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0500684
Registration Date
September 25, 2017
Change Notification Approval Date
March 06, 2025
Retention Due Date
September 24, 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 Prime Plus™ (INT'L) Lithium-ion Rechargeable Battery Smart Battery Charger Lithium-ion Rechargeable Battery BladderScan Prime Plus™ Console BladderScan Prime Plus™ Probe Calibration Tank Kit
Model Identifier(s)
0270-0917 0400-0155 0400-0157 0400-0164 0570-0394 0570-0395 0620-1083