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Qingdao Hightop Biotech Co., Ltd. - Manufacturer Profile

Explore comprehensive manufacturer profile for Qingdao Hightop Biotech Co., Ltd. through Pure Global AI's free EU medical device database. This company manufactures 14 medical devices registered with EUDAMED across 3 risk classes based in China.

This page provides detailed insights including recent registrations, risk class distribution (IVD General: 4, IVD devices for self-testing: 2, IVD Annex II List B: 8), 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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14 Devices
3 Risk Classes
Qingdao Hightop Biotech Co., Ltd.
Manufacturer - China
14
Total Devices
3
Risk Classes
2024
Earliest Version
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Recent Products (Latest 10)
Most recently updated devices in the database
Device NameRisk ClassDetail
FOB Fecal Occult Blood Rapid Test
IVD General
Strep A Antigen Rapid Test (Immunochromatography)
IVD General
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test (Colloidal Gold)
IVD Annex II List B
TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold)
IVD Annex II List B
TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)
IVD Annex II List B
CMV Cytomegalovirus Antibody IgM Rapid Test Kit(Colloidal Gold)
IVD Annex II List B
CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)
IVD Annex II List B
RV Rubella Antibodies IgM/IgG Rapid Test Kit(Colloidal Gold)
IVD Annex II List B
Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)
IVD Annex II List B
TOXO Toxoplasma Antibody IgG Rapid Test Kit (Colloidal Gold)
IVD Annex II List B
Risk Class Distribution
Breakdown by risk classification
IVD Annex II List B
8(57.1%)
IVD General
4(28.6%)
IVD devices for self-testing
2(14.3%)
Top Authorized Representatives
Most common authorized representatives for this manufacturer
Authorized RepresentativeDevice CountPercentageView
MedNet EC-REP GmbH
14100.0%