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166 device results listed.

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SARS-CoV-2 Antigen Rapid Test

SARS-CoV-2 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983167055
Basic UDI-DI: B-06936983167055
Reference: INCP-502H
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Test Card

1N42C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963723277
Basic UDI-DI: B-06921963723277
Reference: 1N42C2
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card (5 tests per box, NL)

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315564
Basic UDI-DI: B-04260163315564
Reference: 07AG6005BSNL
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Netherlands
Authorised representative: -
Last updated: 18.07.2026 22:39

Manufacturer products View details

Rapid SARS-CoV-2 Antigen Test Card (8 tests per box)

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315557
Basic UDI-DI: B-04260163315557
Reference: 07AG6008BS
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 18.07.2026 22:39

Manufacturer products View details

Rapid SARS-CoV-2 Antigen Test Card (7 tests per box)

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315540
Basic UDI-DI: B-04260163315540
Reference: 07AG6007BS
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 18.07.2026 22:39

Manufacturer products View details

Rapid SARS-CoV-2 Antigen Test Card (1 test per box NL)

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315533
Basic UDI-DI: B-04260163315533
Reference: 07AG6001BSNL
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Netherlands
Authorised representative: -
Last updated: 18.07.2026 22:39

Manufacturer products View details

Rapid SARS-CoV-2 Antigen Test Card (5 tests per box)

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315526
Basic UDI-DI: B-04260163315526
Reference: 07AG6005BS
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 18.07.2026 22:39

Manufacturer products View details

Rapid SARS-CoV-2 Antigen Test Card (1 Test Box)

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315519
Basic UDI-DI: B-04260163315519
Reference: 07AG6001BS
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 18.07.2026 22:39

Manufacturer products View details

Rapid SARS-CoV-2 Antigen Test Card (20 tests per box)

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315502
Basic UDI-DI: B-04260163315502
Reference: 07AG6020BS
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 18.07.2026 22:39

Manufacturer products View details

STANDARD™ Q COVID-19 Ag Home Test

Q-NCOV-03G

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725746
Basic UDI-DI: 88001117ISCA01QA032G
Reference: Q-NCOV-03G/ 09COV130
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): SDB-SSP-TDC-QA03 · Rev. 06
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 18.07.2026 06:07

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

STANDARD™ Q COVID-19 Ag Home Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725753
Basic UDI-DI: 88001117ISCA01QA032G
Reference: Q-NCOV-03G/ 09COV130H
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Safety summary (SSCP/SSP): SDB-SSP-TDC-QA03 · Rev. 06
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 18.07.2026 06:06

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

STANDARD™ Q COVID-19 Ag Home Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725760
Basic UDI-DI: 88001117ISCA01QA032G
Reference: Q-NCOV-03G/ 09COV130J
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Safety summary (SSCP/SSP): SDB-SSP-TDC-QA03 · Rev. 06
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 18.07.2026 06:06

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

STANDARD™ Q COVID-19 Ag Home Test

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725777
Basic UDI-DI: 88001117ISCA01QA032G
Reference: Q-NCOV-03G/ 09COV130D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Safety summary (SSCP/SSP): SDB-SSP-TDC-QA03 · Rev. 06
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 18.07.2026 06:06

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

COVID-19 Antigen Rapid Test

COVID-19 Antigen Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304312
Basic UDI-DI: B-69743840304312
Reference: 3021902
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG IgM Rapid Test Kit

COVID-19 IgG IgM Rapid Test Kit

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304244
Basic UDI-DI: B-69743840304244
Reference: 3021901
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)

COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COVAB000FL5QW
Basic UDI-DI: B-697424646COVAB000FL5QW
Reference: COV Ab-4012F
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen FIA Test (Swab)

COVID-19 Antigen FIA Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COVAG000FMUVL
Basic UDI-DI: B-697424646COVAG000FMUVL
Reference: COV Ag-6012F
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM FIA Test (Serum/Plasma)

COVID-19 IgG/IgM FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COVAB001FL8RB
Basic UDI-DI: B-697424646COVAB001FL8RB
Reference: COV Ab-3012F
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Test (FIA)

SARS-CoV-2 Antigen Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5N40C5ZK
Basic UDI-DI: B-5N40C5ZK
Reference: 5N40C5-20-EU, 5N40C5-40-EU
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252088
Basic UDI-DI: B-06976232252088
Reference: CA03-50-422P25
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details