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SD Biosensor STANDARDโ„ข F200 Analyzer - HSA Registration DE0510304

Access comprehensive regulatory information for SD Biosensor STANDARDโ„ข 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.

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CLASS B IVD
DE0510304
SD Biosensor STANDARDโ„ข F200 Analyzer
HSA Registration Number: DE0510304
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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.

Device 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 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)
STANDARDโ„ข F200 Analyzer STANDARDโ„ข F Calibration Kit
Model Identifier(s)
F200 FCAL-10