EUDAMED update: May 25, 2026

Guangdong Wesail Biotech Co., Ltd.

CN-MF-000008828

Active47 devices

Address: Room 204, 5 Hualian Street, Songshan Lake Science and Technology Industrial Park, Songshan Lake, 523808 Dongguan
Role: Manufacturer
Date of registration: Jun 30, 2021
Country: China

Guangdong Wesail Biotech Co., Ltd. is a medical device manufacturer registered in EUDAMED. The company has 47 devices on the EU market across 5 countries. Headquartered in Dongguan, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About Guangdong Wesail Biotech Co., Ltd.

: CN-MF-000008828
Role: Manufacturer
Country: China
Organization name: Guangdong Wesail Biotech Co., Ltd.
EU VAT number: 91441900MA548GY2XX
Date of registration: Jun 30, 2021

Contact details for Guangdong Wesail Biotech Co., Ltd.

Phone: +86-769-22890969
Email: Registration.Wesail@wesailbio.com
Address: ROOM 204, 5 HUALIAN STREET, SONGSHAN LAKE SCIENCE AND TECHNOLOGY INDUSTRIAL PARK, SONGSHAN LAKE 523808 DONGGUAN CHINA

Competent authority

Name: Ministerie van Volksgezondheid, Welzijn en Sport

Phone: +31 70 340 79 11
Email: medische_hulpmiddelen@minvws.nl

Officers and regulatory representatives of Guangdong Wesail Biotech Co., Ltd.

LING Huo
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Connected operators

Importers

1 EU importer places this manufacturer's devices

Data export

Export the 47 devices of Guangdong Wesail Biotech Co., Ltd.

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
25-OH VD Test Kit (FIA)	25-OH VD Test Kit (FIA)	`BA0290`	`06973841001021`	1	On the market
Anti-Mullerian Hormone Test Kit (Immunofluorescence)	Anti-Mullerian Hormone Test Kit (Immunofluorescence)	`BA0190`	`06973841000925`	1	On the market
BNP Test Kit (FIA)	BNP Test Kit (FIA)	`BA0480`	`06973841001168`	1	On the market
C Peptide Test Kit (Immunofluorescence)	C Peptide Test Kit (Immunofluorescence)	`BA0260`	`06973841001151`	1	On the market
C-Reactive Protein Test Kit (Immunofluorescence)	C-Reactive Protein Test Kit (Immunofluorescence)	`BA0150`	`06973841000871`	1	On the market
Central Nerve Specific Protein 100 β Test Kit (Immunofluorescence)	Central Nerve Specific Protein 100 β Test Kit (Immunofluorescence)	`BA0310`	`06973841001014`	1	On the market
COVID-19 Ag Test Kit	COVID-19 Ag Test Kit	`BE0082`	`06973841000185`	1	On the market
COVID-19 Ag Test Kit	COVID-19 Ag Test Kit	`BE0083`	`06973841000208`	1	On the market
COVID-19 Ag Test Kit	COVID-19 Ag Test Kit	`BE0080`	`06973841000130`	1	On the market
COVID-19 Ag Test Kit	COVID-19 Ag Test Kit	`BE0081`	`06973841000147`	1	On the market
Creatine Kinase Isoenzyme-MB Test Kit (Immunofluorescence)	Creatine Kinase Isoenzyme-MB Test Kit (Immunofluorescence)	`BA0110`	`06973841000932`	1	On the market
CRP/SAA Test Kit (FIA)	CRP/SAA Test Kit (FIA)	`BA0390`	`06973841001427`	1	On the market
CRP/SAA Test Kit (FIA)	CRP/SAA Test Kit (FIA)	`BA0390`	`06973841001427`	1	On the market
cTnI/CK-MB/Myo Test Kit (Immunofluorescence)	cTnI/CK-MB/Myo Test Kit (Immunofluorescence)	`BA0130`	`06973841001007`	1	On the market
D-Dimer Test Kit (Immunofluorescence)	D-Dimer Test Kit (Immunofluorescence)	`BA0140`	`06973841000833`	1	On the market
Ferritin Test Kit (Immunofluorescence)	Ferritin Test Kit (Immunofluorescence)	`BA0080`	`06973841001236`	1	On the market
Follicle Stimulating Hormone Test Kit (Immunofluorescence)	Follicle Stimulating Hormone Test Kit (Immunofluorescence)	`BA0380`	`06973841001144`	1	On the market
Free Thyroxine Test Kit (Immunofluorescence)	Free Thyroxine Test Kit (Immunofluorescence)	`BA0370`	`06973841001274`	1	On the market
Glycated Hemoglobin A1c Test Kit (Immunofluorescence)	Glycated Hemoglobin A1c Test Kit (Immunofluorescence)	`BA0040`	`06973841000888`	1	On the market
Handheld Colloidalgold Analyzer	Handheld Colloidalgold Analyzer	`WS-Si1400`	`06973841000284`	1	On the market
Handheld Immunofluorescence Analyzer	Handheld Immunofluorescence Analyzer	`WS-Si1300`	`06973841000277`	1	On the market
Heart Type Fatty Acid Binding Protein Test Kit (Immunofluorescence)	Heart Type Fatty Acid Binding Protein Test Kit (Immunofluorescence)	`BA0200`	`06973841000987`	1	On the market
High Sensitivity Cardiac Troponin I Test Kit (Immunofluorescence)	High Sensitivity Cardiac Troponin I Test Kit (Immunofluorescence)	`BA0010`	`06973841000857`	1	On the market
Human Serum Amyloid A Test Kit (Immunofluorescence)	Human Serum Amyloid A Test Kit (Immunofluorescence)	`BA0160`	`06973841001052`	1	On the market
Immunofluorescence Analyzer	Immunofluorescence Analyzer	`WS-Si1500`	`06973841000826`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
25-OH VD Test Kit (FIA)	25-OH VD Test Kit (FIA)	`BA0290`	`06973841001021`	1	On the market
Anti-Mullerian Hormone Test Kit (Immunofluorescence)	Anti-Mullerian Hormone Test Kit (Immunofluorescence)	`BA0190`	`06973841000925`	1	On the market
BNP Test Kit (FIA)	BNP Test Kit (FIA)	`BA0480`	`06973841001168`	1	On the market
C Peptide Test Kit (Immunofluorescence)	C Peptide Test Kit (Immunofluorescence)	`BA0260`	`06973841001151`	1	On the market
C-Reactive Protein Test Kit (Immunofluorescence)	C-Reactive Protein Test Kit (Immunofluorescence)	`BA0150`	`06973841000871`	1	On the market
Central Nerve Specific Protein 100 β Test Kit (Immunofluorescence)	Central Nerve Specific Protein 100 β Test Kit (Immunofluorescence)	`BA0310`	`06973841001014`	1	On the market
COVID-19 Ag Test Kit	COVID-19 Ag Test Kit	`BE0082`	`06973841000185`	1	On the market
COVID-19 Ag Test Kit	COVID-19 Ag Test Kit	`BE0083`	`06973841000208`	1	On the market
COVID-19 Ag Test Kit	COVID-19 Ag Test Kit	`BE0080`	`06973841000130`	1	On the market
COVID-19 Ag Test Kit	COVID-19 Ag Test Kit	`BE0081`	`06973841000147`	1	On the market
Creatine Kinase Isoenzyme-MB Test Kit (Immunofluorescence)	Creatine Kinase Isoenzyme-MB Test Kit (Immunofluorescence)	`BA0110`	`06973841000932`	1	On the market
CRP/SAA Test Kit (FIA)	CRP/SAA Test Kit (FIA)	`BA0390`	`06973841001427`	1	On the market
CRP/SAA Test Kit (FIA)	CRP/SAA Test Kit (FIA)	`BA0390`	`06973841001427`	1	On the market
cTnI/CK-MB/Myo Test Kit (Immunofluorescence)	cTnI/CK-MB/Myo Test Kit (Immunofluorescence)	`BA0130`	`06973841001007`	1	On the market
D-Dimer Test Kit (Immunofluorescence)	D-Dimer Test Kit (Immunofluorescence)	`BA0140`	`06973841000833`	1	On the market
Ferritin Test Kit (Immunofluorescence)	Ferritin Test Kit (Immunofluorescence)	`BA0080`	`06973841001236`	1	On the market
Follicle Stimulating Hormone Test Kit (Immunofluorescence)	Follicle Stimulating Hormone Test Kit (Immunofluorescence)	`BA0380`	`06973841001144`	1	On the market
Free Thyroxine Test Kit (Immunofluorescence)	Free Thyroxine Test Kit (Immunofluorescence)	`BA0370`	`06973841001274`	1	On the market
Glycated Hemoglobin A1c Test Kit (Immunofluorescence)	Glycated Hemoglobin A1c Test Kit (Immunofluorescence)	`BA0040`	`06973841000888`	1	On the market
Handheld Colloidalgold Analyzer	Handheld Colloidalgold Analyzer	`WS-Si1400`	`06973841000284`	1	On the market
Handheld Immunofluorescence Analyzer	Handheld Immunofluorescence Analyzer	`WS-Si1300`	`06973841000277`	1	On the market
Heart Type Fatty Acid Binding Protein Test Kit (Immunofluorescence)	Heart Type Fatty Acid Binding Protein Test Kit (Immunofluorescence)	`BA0200`	`06973841000987`	1	On the market
High Sensitivity Cardiac Troponin I Test Kit (Immunofluorescence)	High Sensitivity Cardiac Troponin I Test Kit (Immunofluorescence)	`BA0010`	`06973841000857`	1	On the market
Human Serum Amyloid A Test Kit (Immunofluorescence)	Human Serum Amyloid A Test Kit (Immunofluorescence)	`BA0160`	`06973841001052`	1	On the market
Immunofluorescence Analyzer	Immunofluorescence Analyzer	`WS-Si1500`	`06973841000826`	1	On the market

Guangdong Wesail Biotech Co., Ltd.

About Guangdong Wesail Biotech Co., Ltd.

Contact details for Guangdong Wesail Biotech Co., Ltd.

Competent authority

Officers and regulatory representatives of Guangdong Wesail Biotech Co., Ltd.

Connected operators

Importers

Export the 47 devices of Guangdong Wesail Biotech Co., Ltd.

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About Guangdong Wesail Biotech Co., Ltd.

Contact details for Guangdong Wesail Biotech Co., Ltd.

Competent authority

Officers and regulatory representatives of Guangdong Wesail Biotech Co., Ltd.

Statistics for Guangdong Wesail Biotech Co., Ltd.

Certificate health for Guangdong Wesail Biotech Co., Ltd.

Devices by risk class

Market presence of Guangdong Wesail Biotech Co., Ltd.

Device catalog for Guangdong Wesail Biotech Co., Ltd.

Device families (Basic UDI-DI) of Guangdong Wesail Biotech Co., Ltd.

Connected operators

Importers

Export the 47 devices of Guangdong Wesail Biotech Co., Ltd.

Related searches

Certificate health for Guangdong Wesail Biotech Co., Ltd.

Statistics for Guangdong Wesail Biotech Co., Ltd.

Market presence of Guangdong Wesail Biotech Co., Ltd.

Devices by risk class

Device catalog for Guangdong Wesail Biotech Co., Ltd.

Device families (Basic UDI-DI) of Guangdong Wesail Biotech Co., Ltd.