Singapore HSA registration DE0018887
MIR SMART ONE® Spirometer
Singapore·CLASS B·MIR Srl (Medical International Research)·Registered January 20, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0018887
- Registration Date
- January 20, 2017
- Change Notification Approval Date
- April 16, 2020
- Retention Due Date
- January 19, 2026
Product description
MIR SMART ONE® is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in one second). The device is designed for children, adolescent and adult subjects. MIR SMART ONE® is indicated for monitoring asthma, COPD and other respiratory diseases.
Product Owner
- Short Name
- MIR Srl
- Address
- Via del Maggiolino, 125, 00155 Roma, ITALY
Registrant
- Address
- 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Importer
- Address
- 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Model information
- Model Name(s)
- MIR SmartOne®
- Model Identifier(s)
- 911100
About this record
Access comprehensive regulatory information for MIR SMART ONE® Spirometer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018887 and owned by MIR Srl (Medical International Research). The device was registered on January 20, 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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