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727 device results listed.

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Smart Rapid COVID-19 Ag Test Device

GCCOV-503a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-503a4D
Basic UDI-DI: B-GCCOV-503a4D
Reference: GCCOV-503a
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 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Coronavirus Ag Rapid Test Cassette (Swab)

GCCOV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a4A
Basic UDI-DI: B-GCCOV-502a4A
Reference: GCCOV-502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Coronavirus Ag Rapid Test Cassette (Swab)

GCCOV-502a-NN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-NNAM
Basic UDI-DI: B-GCCOV-502a-NNAM
Reference: GCCOV-502a-NN
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Coronavirus Ag Rapid Test Cassette (Swab)

GCCOV-502a-NA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-NA9T
Basic UDI-DI: B-GCCOV-502a-NA9T
Reference: GCCOV-502a-NA
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H8OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H8OGEG8
Basic UDI-DI: B-GCCOV-502a-H8OGEG8
Reference: GCCOV-502a-H8OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H7OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H7OGEFZ
Basic UDI-DI: B-GCCOV-502a-H7OGEFZ
Reference: GCCOV-502a-H7OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H5OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H5OGEFK
Basic UDI-DI: B-GCCOV-502a-H5OGEFK
Reference: GCCOV-502a-H5OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H3OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H3OGEF5
Basic UDI-DI: B-GCCOV-502a-H3OGEF5
Reference: GCCOV-502a-H3OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H25OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H25OGEUB
Basic UDI-DI: B-GCCOV-502a-H25OGEUB
Reference: GCCOV-502a-H25OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H20OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H20OGET8
Basic UDI-DI: B-GCCOV-502a-H20OGET8
Reference: GCCOV-502a-H20OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H1OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H1OGEEP
Basic UDI-DI: B-GCCOV-502a-H1OGEEP
Reference: GCCOV-502a-H1OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H15OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H15OGETY
Basic UDI-DI: B-GCCOV-502a-H15OGETY
Reference: GCCOV-502a-H15OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H10OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H10OGESV
Basic UDI-DI: B-GCCOV-502a-H10OGESV
Reference: GCCOV-502a-H10OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
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

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCOV-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-402a43
Basic UDI-DI: B-GCCOV-402a43
Reference: GCCOV-402a
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCOV-402Ba

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-402BaY7
Basic UDI-DI: B-GCCOV-402BaY7
Reference: GCCOV-402Ba
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma)

GCCOV(NAb)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV(NAb)-402bCQ
Basic UDI-DI: B-GCCOV(NAb)-402bCQ
Reference: GCCOV(NAb)-402b
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - 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 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

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 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 Antigen Control Kit

GCCOV(Ag)-PN10，GCCOV(Ag)-PN20

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV(Ag)-PNF6
Basic UDI-DI: B-GCCOV(Ag)-PNF6
Reference: GCCOV(Ag)-PN10，GCCOV(Ag)-PN20
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details