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129 device results listed.

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Rapid COVID-19 Antigen Test Strip

GCCOV-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-501aHG49
Basic UDI-DI: B-GCCOV-501aHG49
Reference: GCCOV-501a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Test Strip

GCCOV-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-501a47
Basic UDI-DI: B-GCCOV-501a47
Reference: GCCOV-501a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:24

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SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)

GCCOV(Del)-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV(Del)-T502aUL
Basic UDI-DI: B-GCCOV(Del)-T502aUL
Reference: GCCOV(Del)-T502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)

GCCOV(Del)-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV(Del)-T502aHGQG
Basic UDI-DI: B-GCCOV(Del)-T502aHGQG
Reference: GCCOV(Del)-T502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab)

GCCOV(B117)-525a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV(B117)-525aKE
Basic UDI-DI: B-GCCOV(B117)-525aKE
Reference: GCCOV(B117)-525a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab)

GCCOV(B117)-525a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV(B117)-525aHGE5
Basic UDI-DI: B-GCCOV(B117)-525aHGE5
Reference: GCCOV(B117)-525a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)

FCCOV-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCCOV-502aHG3B
Basic UDI-DI: B-FCCOV-502aHG3B
Reference: FCCOV-502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCCOV-502a3D
Basic UDI-DI: B-FCCOV-502a3D
Reference: FCCOV-502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-COVID-502bA5
Basic UDI-DI: B-COVID-502bA5
Reference: COVID-502b
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Spain
Authorised representative: HUMISS TRADING S. L.
Last updated: 13.07.2026 07:19

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COVID-19 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-COVID-19-B026L
Basic UDI-DI: B-COVID-19-B026L
Reference: COVID-19-B02
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

COVID 19 Antigen Test Kit (Colloidal Gold Method)

SVRAG89

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610580
Basic UDI-DI: B-86979834610580
Reference: SVRAG89
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 12.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

COVID-19 Antigen Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763037
Basic UDI-DI: B-15065023763037
Reference: TV10004
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:33

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA W COVID-19 Ag