Singapore HSA registration DE0506993
OMRON WheezeScan Wheeze Detector
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 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.
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)
About this record
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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