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Shenzhen Microprofit Biotech Co., Ltd

China Last updated 8 Jun 2026

Devices
174
Registries
EUDAMED
FDA recalls
0

Catalogue174

Page 1 of 4

Showing 1-50 of 174

EUDAMED certificates1

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • V76 109172 0008 Issued

    Technical documentation EU IVDR

    Issued
    9 Oct 2025
    Expires
    8 Oct 2030

Authorised representatives

Notified bodies

What Shenzhen Microprofit Biotech Co., Ltd makes

The company manufactures medical incubators for controlled environmental conditions, as well as rapid diagnostic test kits using colloidal gold chromatographic immunoassay technology. These include antigen test kits for SARS-CoV-2 (including saliva-based versions), combined antigen tests for SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV), and diagnostic kits for prostate-specific antigen (PSA) and free PSA (f-PSA). It also produces a dry-type immunofluorescence quantitative analyzer for laboratory use.

The portfolio includes Class A medical devices and in vitro diagnostic (IVD) products, including those listed under Annex II List B and self-testing IVDs. These devices are registered in the EU’s eudamed database, and the company is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Shenzhen Microprofit Biotech Co., Ltd have in the registry?

The registry currently lists 174 devices for Shenzhen Microprofit Biotech Co., Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shenzhen Microprofit Biotech Co., Ltd's devices?

Among its 50 most recently registered devices, Shenzhen Microprofit Biotech Co., Ltd has devices listed in EUDAMED (50 devices).

What risk classes do Shenzhen Microprofit Biotech Co., Ltd's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Shenzhen Microprofit Biotech Co., Ltd's devices are IVDR Class A, IVDR Class B, IVDR Class C and IVD general. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Shenzhen Microprofit Biotech Co., Ltd?

EUDAMED lists 1 certificate for Shenzhen Microprofit Biotech Co., Ltd (technical documentation) under IVDR. 1 is recorded with the status issued. The most recent was issued on 2025-10-09.

What are the newest devices from Shenzhen Microprofit Biotech Co., Ltd in the registry?

The most recently registered devices listed for Shenzhen Microprofit Biotech Co., Ltd include Cortisol (Cor) Diagnostic Kit(Immunochromatographic Assay), Prolactin (PRL) Diagnostic Kit (Immunochromatographic Assay), SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) and Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay).

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
Room 1001 of Unit 2, Room 1001 and Room 1101 of Unit 1, Building 2, Hongchuang Technology Center, Xikeng Community, Fucheng Sub-district, Longhua District,, Shenzhen, China
Phone
+86 755 61688835
PRRC contact
Jihui Zheng
EUDAMED SRN
CN-MF-000019518