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MIR SMART ONE® Spirometer - HSA Registration DE0018887

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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CLASS B
DE0018887
MIR SMART ONE® Spirometer
HSA Registration Number: DE0018887
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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.

Device 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 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