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Singapore HSA registration DE0508639

ForaCare FORA 6 Blood Glucose- Hematocrit-Hemoglobin Test System

Singapore flagSingapore·CLASS C IVD·ForaCare Suisse AG·Registered November 06, 2023
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0508639
Registration Date
November 06, 2023
Retention Due Date
November 05, 2025
Product description
FORA 6 test strips, when used together with FORA 6 Plus / Connect Multi-functional Monitoring System is intended for the quantitative measurement of blood glucose, hematocrit and hemoglobin in fresh capillary whole blood from the finger. It is for in vitro diagnostic use only. This system is not intended for use in the diagnosis or screening of diabetes mellitus. Home use is limited to capillary whole blood testing. Professionals may test with venous blood sample.
Product Owner
Name
ForaCare Suisse AG
Short Name
ForaCare Suisse AG
Address
Neugasse 55, CH-9000 St. Gallen, Switzerland, SWITZERLAND
Registrant
Name
UNISON COLLABORATIVE PTE. LTD.
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
Name
UNISON COLLABORATIVE PTE. LTD.
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
Model Name(s)
ForaCare FORA 6 Glucose Control Level 1 ForaCare FORA 6 Glucose Control Level 2 ForaCare FORA 6 Glucose Control Level 3 ForaCare FORA 6 Sterile Lancet ForaCare FORA 6 Blood Glucose Test Strip ForaCare FORA 6 Blood Glucose Test Strip ForaCare FORA 6 Blood Glucose-Hematocrit- Hemoglobin Test Strip ForaCare FORA 6 Blood Glucose-Hematocrit- Hemoglobin Test Strip ForaCare FORA 6 Plus ForaCare FORA 6 Connect
Model Identifier(s)
ACS017 ACS018 ACS019 ACS024 ACS045 (25pcs) ACS045 (50pcs) ACS051 (25pcs) ACS051 (50pcs) GD81 GD82
About this record

Access comprehensive regulatory information for ForaCare FORA 6 Blood Glucose- Hematocrit-Hemoglobin Test System in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0508639 and owned by ForaCare Suisse AG. The device was registered on November 06, 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 C IVD