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Sansure Biotech Inc. - Manufacturer Profile

Explore comprehensive manufacturer profile for Sansure Biotech Inc. through Pure Global AI's free EU medical device database. This company manufactures 1247 medical devices registered with EUDAMED across 6 risk classes based in China.

This page provides detailed insights including recent registrations, risk class distribution (IVD General: 1198, Class A: 33, IVD Annex II List B: 3, IVD Annex II List A: 3, IVD devices for self-testing: 4, ...), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.

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1247 Devices
6 Risk Classes
Sansure Biotech Inc.
Manufacturer - China
1247
Total Devices
6
Risk Classes
2022
Earliest Version
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Recent Products (Latest 10)
Most recently updated devices in the database
Device NameRisk ClassDetail
Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)
IVD General
Nucleic Acid Extraction-Purification Kit V-VI
Class A
Nucleic Acid Extraction-Purification Kit V-VI
Class A
Nucleic Acid Extraction-Purification Kit V-VI
Class A
Nucleic Acid Extraction-Purification Kit V-VI
Class A
Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method)
Class A
Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method)
Class A
Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method)
Class A
Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Class C
Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Class C
Risk Class Distribution
Breakdown by risk classification
IVD General
1198(96.1%)
Class A
33(2.6%)
Class C
6(0.5%)
IVD devices for self-testing
4(0.3%)
IVD Annex II List B
3(0.2%)
IVD Annex II List A
3(0.2%)
Top Authorized Representatives
Most common authorized representatives for this manufacturer
Authorized RepresentativeDevice CountPercentageView
Obelis s.a.
121097.0%
Lotus NL B.V.
252.0%
OSEN
121.0%