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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

MP Diagnostics ASSURE H. pylori Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000740
Basic UDI-DI: B-08887581000740
Reference: 43490-020
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 18.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors 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

Flu A+B Test (Swab/Nasal Aspirate)

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: D-SW02-FLAB(PRO)CM
Basic UDI-DI: B-SW02-FLAB(PRO)CM
Reference: SW02-FLAB(PRO)
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A (H5) Ag Rapid Test Cassette (Swab)

GCFLU(AH5)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(AH5)-502aOGKU
Basic UDI-DI: B-GCFLU(AH5)-502aOGKU
Reference: GCFLU(AH5)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A (H5) Ag Rapid Test Cassette (Swab)

GCFLU(AH5)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(AH5)-502aHGK7
Basic UDI-DI: B-GCFLU(AH5)-502aHGK7
Reference: GCFLU(AH5)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A Ag Rapid Test Cassette (Swab)

GCFLU(A)-U502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A)-U502aOG5L
Basic UDI-DI: B-GCFLU(A)-U502aOG5L
Reference: GCFLU(A)-U502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A Ag Rapid Test Cassette (Swab)

GCFLU(A)-U502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(A)-U502aHG4X
Basic UDI-DI: B-GCFLU(A)-U502aHG4X
Reference: GCFLU(A)-U502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252194
Basic UDI-DI: B-06976232252194
Reference: CA03-88-422P20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test

COVID-19/ Influenza A+B/RSV Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RV-G45bZV
Basic UDI-DI: B-RV-G45bZV
Reference: RV-G45b
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Vibrio Cholerae O139,O1 Ogawa & Inaba Combo Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-VC01C66C
Basic UDI-DI: B-L11-VC01C66C
Reference: L11-VC01C6
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVCAI-R602BC
Basic UDI-DI: B-IVCAI-R602BC
Reference: IVCAI-R602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio cholerae O139 (VC O139) Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVCB-R6029V
Basic UDI-DI: B-IVCB-R6029V
Reference: IVCB-R602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details