EU Manufacturer 🇨🇳 China Active

Qingdao Hightop Biotech Co., Ltd.

SRN: CN-MF-000016890 · Hedong Road No.369, 266112 Qingdao, Shandong, China
Basic UDI-DIs
14
Total Devices
14
On Market
14
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
0

Basic Information

Address
Hedong Road No.369, 266112 Qingdao, Shandong, China

Regulatory Overview

Regulation
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Eu Ivdd 14
Classification
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Eu Ivd Annex 2 List B 8
Eu Ivd General 4
Eu Ivd Self Testing 2
Device Types
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Certificate Health

Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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Type Number Expiry Date Status
IVDD Annex IV (excluding sections 4, 6) No.V1093780 0004 May 26, 2025
IVDD Annex IV (excluding sections 4, 6) No. V1 093780 0004 May 26, 2025
IVDD Annex IV (excluding sections 4, 6) W0105099001 May 26, 2025
IVDD Annex IV (excluding sections 4, 6) No. V1 093780 0004 Rev. 01 May 26, 2025

Device Portfolio

Name
CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold)
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold)
Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)
FOB Fecal Occult Blood Rapid Test
One Step HCG Urine Pregnancy Rapid Test Kit (Colloidal Gold)
One Step LH Ovulation Rapid Test Kit(Colloidal Gold)
RV Rubella Antibodies IgM/IgG Rapid Test Kit(Colloidal Gold)
SARS-CoV-2/Flu A+B/AdV/RSV Antigen Rapid Test
SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test
Strep A Antigen Rapid Test (Immunochromatography)
TOXO Toxoplasma Antibody IgG Rapid Test Kit (Colloidal Gold)
TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold)
TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)