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Singapore HSA registration DE0507756

Sibelmed DATOSPIR touch Spirometer

Singapore flagSingapore·CLASS B·SIBEL SAU·Registered February 08, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0507756
Registration Date
February 08, 2023
Change Notification Approval Date
November 13, 2024
Retention Due Date
February 07, 2026
Product description
a) Measurement of lung flows and volumes for the diagnostic and control of respiratory diseases (Asthma, COPD, etc.). b) Measurement of peripheral blood oxygen saturation and cardiac pulse for the respiratory diagnostic. c) Measurement of inspiratory and expiratory maxima pressures for the respiratory diagnostic.
Product Owner
Name
SIBEL SAU
Short Name
SIBEL SAU
Address
Raimon Casellas, 6-8., 08205, Sabadell, SPAIN
Registrant
Name
DANMEDIK (S) PRIVATE LIMITED
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Importer
Name
DANMEDIK (S) PRIVATE LIMITED
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Model information
Model Name(s)
Pediatric Mouthpiece adapter Thermal Paper Nose clip Disposable transducer Turbine Calibration Adaptor Fleisch Filter Turbine transducer kit Transducer Holder Carrying Bag Calibration syringe Bacterial-Viral filter Disposable Transducer with Filter Datospir Touch Easy-D Datospir Touch Easy-F Datospir Touch Easy-T Datospir Touch Diagnostic-D Datospir Touch Diagnostic-F Datospir Touch Diagnostic-T Disposable transducer Module Fleisch transducer Module Turbine transducer Module
Model Identifier(s)
1149 2634 2692 3169 3175 5636 6187 7053 7155 7283 8290 9698 9718 9877 9878 9879 9880 9881 9882 9888 9889 9890
About this record

Access comprehensive regulatory information for Sibelmed DATOSPIR touch 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 DE0507756 and owned by SIBEL SAU. The device was registered on February 08, 2023.

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