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Singapore HSA registration DE0506952

MIR Smart One Oxi Spirometer and Pulse Oximeter

Singapore flagSingapore·CLASS B·MIR Srl (Medical International Research)·Registered June 14, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0506952
Registration Date
June 14, 2022
Retention Due Date
June 13, 2025
Product description
The Smart One Oxi Spirometer and Pulse Oximeter is intended to be used by a physician or by a subject under the instructions of a physician or paramedic to assess lung function. The device is designed for children over five years of age, adolescents and adults, and can be used at home, in a factory, pharmacy, hospital or medical surgery. It measures the PEF (Peak Expiratory Flow) and the FEV1 (maximal expiratory volume in the 1st second, VEMS). The device also measures the parameters related to the oximetry test in particular the SpO2 and the BPM.
Product Owner
Name
MIR Srl (Medical International Research)
Short Name
MIR Srl
Address
Via del Maggiolino, 125, 00155 Roma, ITALY
Registrant
Name
EO MEDICAL PTE. LTD.
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Importer
Name
EO MEDICAL PTE. LTD.
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Model information
Model Name(s)
MIR Smart One Oxi Spirometer and Pulse Oximeterer SmartOne Android SmartOne IOS
Model Identifier(s)
911120 SmartOne Android SmartOne IOS
About this record

Access comprehensive regulatory information for MIR Smart One Oxi Spirometer and Pulse Oximeter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506952 and owned by MIR Srl (Medical International Research). The device was registered on June 14, 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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