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Singapore HSA registration DE0506768

TNI softFlow

Singapore flagSingapore·CLASS B·TNI MEDICAL AG·Registered March 31, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0506768
Registration Date
March 31, 2022
Retention Due Date
March 30, 2026
Product description
The TNI softFlow 50 system is for the treatment of spontaneously breathing patients who would benefit from receiving a high flow of warmed and humidified respiratory gases. The TNI softFlow 50 system is for adult patients in hospitals and long-term care facilities. The flow may be from 10-50 l/min. The TNI softFlow 50 is not indicated for life support measures.
Product Owner
Name
TNI MEDICAL AG
Short Name
TNI MEDICAL AG
Address
Tiefe Gasse 11-13, 97084 Wurzburg, Wurzburg, GERMANY
Registrant
Name
MASIMO ASIA PACIFIC PTE. LTD.
Address
31 UBI ROAD 1, #04-05, SINGAPORE 408694
Importer
Name
MASIMO ASIA PACIFIC PTE. LTD.
Address
31 UBI ROAD 1, #04-05, SINGAPORE 408694
Model information
Model Name(s)
softFlow Applicator Clinic Small softFlow Applicator Clinic Standard softFlow Applicator Clinic Standard Plus softFlow Applicator Clinic Standard Large softFlow
Model Identifier(s)
4738 4739 4740 4741 9007
About this record

Access comprehensive regulatory information for TNI softFlow in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506768 and owned by TNI MEDICAL AG. The device was registered on March 31, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B