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OMRON WheezeScan Wheeze Detector - HSA Registration DE0506993

Access comprehensive regulatory information for OMRON WheezeScan Wheeze Detector in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506993 and owned by OMRON HEALTHCARE Co., Ltd. The device was registered on June 23, 2022.

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
DE0506993
OMRON WheezeScan Wheeze Detector
HSA Registration Number: DE0506993
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Product Description

The OMRON WheezeScan is intended to detect the presence of wheezing in infants, toddlers and children from 4 months to 7 years of age.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0506993
Registration Date
June 23, 2022
Retention Due Date
June 22, 2025
Product Owner
Short Name
OMRON HEALTHCARE Co., Ltd
Address
53, Kunotsubo Terado-cho, Muko, Kyoto, 617-0002, JAPAN
Registrant
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-01/02, SINGAPORE 119968
Importer
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-01/02, SINGAPORE 119968
Model Information
Model Name(s)
OMRON Wheeze Detector WheezeScan (HWZ-1000T-E)
Model Identifier(s)
WheezeScan (HWZ-1000T-E)