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166 device results listed.

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08800111715778

Q-NCOV-07G

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111715778
Basic UDI-DI: 88001117IPBA04QA04YQ
Reference: Q-NCOV-07G/ 09COV176D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111715761

Q-NCOV-07G

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111715761
Basic UDI-DI: 88001117IPBA02QA04Y2
Reference: Q-NCOV-07G/ 09COV175D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111715754

Q-NCOV-07G

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111715754
Basic UDI-DI: 88001117IPBA03QA04YD
Reference: Q-NCOV-07G/ 09COV173D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111715747

Q-NCOV-07G

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111715747
Basic UDI-DI: 88001117IPBA01QA04XP
Reference: Q-NCOV-07G/ 09COV172D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

06933289816809

2019-nCoV Antigen Test (Lateral Flow Method)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289816809
Basic UDI-DI: 69332898CE1606FH
Reference: W634P0024
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: France
Safety summary (SSCP/SSP): CSD-W634(2)-01-06 · Rev. 04
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:29

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

06933289816816

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289816816
Basic UDI-DI: 69332898CE1606FH
Reference: W634P0025
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CSD-W634(2)-01-06 · Rev. 04
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:58

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

06933289816823

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289816823
Basic UDI-DI: 69332898CE1606FH
Reference: W634P0026
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CSD-W634(2)-01-06 · Rev. 04
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:58

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

NADAL® COVID-19 Ag Test

COVID-19 Ag Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-243103N-25PARX
Basic UDI-DI: B-nvm-243103N-25PARX
Reference: 243103N-25PA
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® COVID-19 IgG/IgM Test

COVID-19 IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-243001N-10TU
Basic UDI-DI: B-nvm-243001N-10TU
Reference: 243001N-10
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

SARS-CoV-2 S-RBD IgG Ab Rapid Test

VCD25-01-013

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VCD25-01-0132R
Basic UDI-DI: B-VCD25-01-0132R
Reference: VCD25-01-013
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 IgG Rapid Test

VCD24-01-013

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VCD24-01-01326
Basic UDI-DI: B-VCD24-01-01326
Reference: VCD24-01-013
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SC2GMAb801B9
Basic UDI-DI: B-SC2GMAb801B9
Reference: SC2GMAb801
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 (COVID-19) Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INCP-RG502CE
Basic UDI-DI: B-INCP-RG502CE
Reference: INCP-RG502
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Ag Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD149XU
Basic UDI-DI: B-GKPD149XU
Reference: GKPD149
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

MERS-CoV Antigen Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD125XE
Basic UDI-DI: B-GKPD125XE
Reference: GKPD125
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Digital COVID-19 Ag Rapid Test (Swab)

GCCOV-D503a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-D503aHGGU
Basic UDI-DI: B-GCCOV-D503aHGGU
Reference: GCCOV-D503a
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

Digital COVID-19 Ag Rapid Test (Swab)

GCCOV-D503a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-D503a4W
Basic UDI-DI: B-GCCOV-D503a4W
Reference: GCCOV-D503a
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

COVID-19 Ag Rapid Test Cassette (Oral Fluid)

GCCOV-702a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-702aHG5A
Basic UDI-DI: B-GCCOV-702aHG5A
Reference: GCCOV-702a
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

COVID-19 Ag Rapid Test Cassette (Oral Fluid)

GCCOV-702a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-702a4Q
Basic UDI-DI: B-GCCOV-702a4Q
Reference: GCCOV-702a
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

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