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721 device results listed.

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COVID-19 IgG Test Kit

COV-W35

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803155
Basic UDI-DI: B-06952804803155
Reference: COV-W35
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Neutralizing Antibody Rapid Test

COV-W23001

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803148
Basic UDI-DI: B-06952804803148
Reference: COV-W23001
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19&FLU A/B FIA

MI-S22MF3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802912
Basic UDI-DI: B-06952804802912
Reference: MI-S22MF3
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen FIA

COV-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802905
Basic UDI-DI: B-06952804802905
Reference: COV-S23F3
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

06952804800697

Adenovirus Respiratory Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804800697
Basic UDI-DI: B-06952804800697
Reference: /
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062710707
Basic UDI-DI: 69520627J017LD
Reference: COVAg+FluAB1NST-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CE81-COVAg+FluAB-6.6 · Rev. A5
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 28.06.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Rapid Flu A&B+RSV+Adeno Antigen Test

GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-DRH20

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004114
Basic UDI-DI: 69509960GCFRA-T525aDRH3A
Reference: GCFRA-T525a-DRH20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-SSP-OG009 · Rev. 01
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Rapid Flu A&B+RSV+Adeno Antigen Test

GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-DRH20

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004107
Basic UDI-DI: 69509960GCFRA-T525aDRH3A
Reference: GCFRA-T525a-DRH7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-SSP-OG009 · Rev. 01
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Rapid Flu A&B+RSV+Adeno Antigen Test

GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-DRH20

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004091
Basic UDI-DI: 69509960GCFRA-T525aDRH3A
Reference: GCFRA-T525a-DRH5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-SSP-OG009 · Rev. 01
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Rapid Flu A&B+RSV+Adeno Antigen Test

GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-DRH20

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004084
Basic UDI-DI: 69509960GCFRA-T525aDRH3A
Reference: GCFRA-T525a-DRH1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-SSP-OG009 · Rev. 01
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

GCFCRA-T525a-DR

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002844
Basic UDI-DI: 69509960GCFCRA-T525aDR65
Reference: GCFCRA-T525a-DR
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)

GCFC-T502a-H1， GCFC-T502a-H2， GCFC-T502a-H4， GCFC-T502a-H5， GCFC-T502a-H7 ，GCFC-T502a-H20