Singapore HSA registration DE0510304
SD Biosensor STANDARD™ F200 Analyzer
Singapore·CLASS B IVD·SD Biosensor, Inc.·Registered February 05, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0510304
- Registration Date
- February 05, 2025
- Retention Due Date
- February 04, 2026
Product description
The STANDARD F200 Analyzer works for measuring quantitative or qualitative biomarker with body fluid such as blood, urine, nasal mucus, and so on based in vitro diagnostic assays in laboratory and point-of-care settings. The analyzer is indicated for monitoring and diagnosing from the body fluid parameter in clinical settings by healthcare professionals. The analyzer should be used with the specified test device which produced by SD BIOSENSOR, Inc.
Product Owner
- Short Name
- SD Biosensor, Inc.
- Address
- C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, KOREA, REPUBLIC OF
Registrant
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
- Model Name(s)
- STANDARD™ F200 Analyzer STANDARD™ F Calibration Kit
- Model Identifier(s)
- F200 FCAL-10
About this record
Access comprehensive regulatory information for SD Biosensor STANDARD™ F200 Analyzer 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 DE0510304 and owned by SD Biosensor, Inc.. The device was registered on February 05, 2025.
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 IVD