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Singapore HSA registration DE0510054

Restech FIRST

Singapore flagSingapore·CLASS B·Restech Srl·Registered November 19, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0510054
Registration Date
November 19, 2024
Retention Due Date
November 18, 2025
Product description
FIRST is intended to measure respiratory system impedance using the Forced Oscillation Technique. FIRST is intended for use with pediatric and adult patients 3 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, private physician offices, pharmacies and health-check centers.
Product Owner
Name
Restech Srl
Short Name
Restech Srl
Address
Via Melchiorre Gioia, 61/63,, 20124 Milano, Italy, ITALY
Registrant
Name
SOMNOTEC (S) PTE. LTD.
Address
37 UBI CRESCENT, SINGAPORE 408586
Importer
Name
SOMNOTEC (S) PTE. LTD.
Address
37 UBI CRESCENT, SINGAPORE 408586
Model information
Model Name(s)
FIRST
Model Identifier(s)
RT1105
About this record

Access comprehensive regulatory information for Restech FIRST in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510054 and owned by Restech Srl. The device was registered on November 19, 2024.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B