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Singapore HSA registration DE0503386

Geratherm Respiratory Diffustik

Singapore flagSingapore·CLASS B·Geratherm Respiratory GmbH·Registered July 19, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0503386
Registration Date
July 19, 2019
Retention Due Date
July 18, 2025
Product description
Diffustik is a PC based system, which is used for the determination of the diffusion capacity in lung function measurements. The main application of the Diffustik is PFT measurement used in clinical environment.
Product Owner
Name
Geratherm Respiratory GmbH
Short Name
Geratherm Respiratory GmbH
Address
Kasernenstraße 4, 97688 Bad Kissingen, GERMANY
Registrant
Name
WALEN TEC ASIA PTE LTD
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Importer
Name
WALEN TEC ASIA PTE LTD
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Model information
Model Name(s)
Height adjustable arm CO/CH4 Gas Analyzer Table clamp arm Diffustik PFT Cart Calibration Syringe
Model Identifier(s)
281404 384660 420241 455713 509409 608220
About this record

Access comprehensive regulatory information for Geratherm Respiratory Diffustik in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503386 and owned by Geratherm Respiratory GmbH. The device was registered on July 19, 2019.

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