Pure Global

ForaCare FORA 6 β-ketone Test System - HSA Registration DE0508640

Access comprehensive regulatory information for ForaCare FORA 6 β-ketone Test System in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0508640 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0508640
ForaCare FORA 6 β-ketone Test System
HSA Registration Number: DE0508640
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

FORA 6 β-Ketone test strips, when used together with FORA 6 Plus / FORA 6 Connect Multi-functional meter, allow your β-Ketone levels to be measured by yourself at home or by healthcare professionals. It uses fresh whole blood samples from the finger. This system is not intended for use in the diagnosis or screening of diabetes mellitus. Professionals may test with capillary and venous blood sample; home use is limited to capillary whole blood testing.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0508640
Registration Date
November 06, 2023
Retention Due Date
November 05, 2025
Product Owner
Short Name
ForaCare Suisse AG
Address
Neugasse 55, CH-9000 St. Gallen, Switzerland, SWITZERLAND
Registrant
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model Information
Model Name(s)
ForaCare FORA 6 Sterile Lancet ForaCare FORA 6 Ketone Control Level 1 ForaCare FORA 6 Ketone Control Level 2 ForaCare FORA 6 Ketone Control Level 3 ForaCare FORA 6 β-ketone Test Strip ForaCare FORA 6 β-ketone Test Strip ForaCare FORA 6 Plus ForaCare FORA 6 Connect
Model Identifier(s)
ACS024 ACS027 ACS028 ACS029 ACS053 (10pcs) ACS053 (25pcs) GD81 GD82