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Last updated

22.09.2026 16:13

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Active filter:EMDN:W01050990

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06975146600022

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testing
Manufacturer
BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000001098
UDI-DI
06975146600022
Basic UDI-DI
B-06975146600022
Reference
20 tests/package
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Poland
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975146600015

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testing
Manufacturer
BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000001098
UDI-DI
06975146600015
Basic UDI-DI
B-06975146600015
Reference
5tests/package
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Poland
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975146600008

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testing
Manufacturer
BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000001098
UDI-DI
06975146600008
Basic UDI-DI
B-06975146600008
Reference
1 test/package
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Poland
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 22:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462511

COVID-19 Neutralizing Antibody Rapid Test Kit (Immunofluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462511
Basic UDI-DI
B-06975132462511
Reference
ICOVN-402F-1
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462436

COVID-19 Neutralizing Antibodies Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462436
Basic UDI-DI
B-06975132462436
Reference
ICOVN-402G-6
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462429

COVID-19 Neutralizing Antibodies Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462429
Basic UDI-DI
B-06975132462429
Reference
ICOVN-402G-5
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462412

COVID-19 Neutralizing Antibodies Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462412
Basic UDI-DI
B-06975132462412
Reference
ICOVN-402G-4
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462320

COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462320
Basic UDI-DI
B-06975132462320
Reference
ICOVS-702G-2
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462313

COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462313
Basic UDI-DI
B-06975132462313
Reference
ICOVS-702G-1
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462221

COVID-19/Influenza A&B Antigen Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462221
Basic UDI-DI
B-06975132462221
Reference
ICMCAB-502G-2
EMDN
W0105099004
EMDN description
INFLUENZA A AND /OR B - RT & POC
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462214

COVID-19/Influenza A&B Antigen Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462214
Basic UDI-DI
B-06975132462214
Reference
ICMCAB-502G-1
EMDN
W0105099004
EMDN description
INFLUENZA A AND /OR B - RT & POC
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462139

COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462139
Basic UDI-DI
B-06975132462139
Reference
ICOV-502G-2
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462122

COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462122
Basic UDI-DI
B-06975132462122
Reference
ICOV-502G-3
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462115

COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462115
Basic UDI-DI
B-06975132462115
Reference
ICOV-502G-1
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462023

Influenza A&B Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462023
Basic UDI-DI
B-06975132462023
Reference
ICMAB-502G-2
EMDN
W0105099004
EMDN description
INFLUENZA A AND /OR B - RT & POC
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132462016

Influenza A&B Rapid Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132462016
Basic UDI-DI
B-06975132462016
Reference
ICMAB-502G-1
EMDN
W0105099004
EMDN description
INFLUENZA A AND /OR B - RT & POC
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975132461620

Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Jiangsu Accuracy Biotechnology Co.,Ltd.
Manufacturer SRN
CN-MF-000004533
UDI-DI
06975132461620
Basic UDI-DI
B-06975132461620
Reference
ICOV-402G-2
EMDN
W0105099099
EMDN description
VIROLOGY - RT & POC - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 21:58
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details