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897 device results listed.

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FluCov2

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251201583
Basic UDI-DI: B-05200251201583
Reference: FLCVCH
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:48

Manufacturer products View details

Capilia hMPV Test Plate 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815016715
Basic UDI-DI: B-04987815016715
Reference: CAHM1671
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:45

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia hMPV 20T/Box

IVD generalNot specifiedOn the marketSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815016708
Basic UDI-DI: B-04987815016708
Reference: CAHM1670
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Mycoplasma 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815015718
Basic UDI-DI: B-04987815015718
Reference: CAMP1571
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Strep A 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815011703
Basic UDI-DI: B-04987815011703
Reference: CAST1170
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Adeno Neo Test Plate 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815003715
Basic UDI-DI: B-04987815003715
Reference: CAAD0371
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Adeno Neo 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815003708
Basic UDI-DI: B-04987815003708
Reference: CAAD0370
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104746
Basic UDI-DI: 6970277510001CXJ
Reference: IRO-N602-20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104630
Basic UDI-DI: 6970277510000YYT
Reference: IAD-N602-20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062778066
Basic UDI-DI: 69520627J012L3
Reference: SL030101NST-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CE14-COVAg-6.6 · Rev. A/4
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

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

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062774020
Basic UDI-DI: 69520627J034LD
Reference: CFRA1ST-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CE80-CFRA-6-6 · Rev. A7
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

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

Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062710714
Basic UDI-DI: 69520627J017LD
Reference: COVAg+FluAB1NST-5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Safety summary (SSCP/SSP): SL-CE81-COVAg+FluAB-6.6 · Rev. A5
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

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

HPIV Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IPIV-ACO502GM
Basic UDI-DI: B-IPIV-ACO502GM
Reference: IPIV-ACO502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Greece
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

West Nile Virus IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: D-BSP02-WNGMZE
Basic UDI-DI: B-BSP02-WNGMZE
Reference: BSP02-WNGM
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IRO-ACO60795
Basic UDI-DI: B-IRO-ACO60795
Reference: IRO-ACO607
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-INO-ACO60769
Basic UDI-DI: B-INO-ACO60769
Reference: INO-ACO607
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 and M. pneumoniae IgG Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INMCG-425BM
Basic UDI-DI: B-INMCG-425BM
Reference: INMCG-425
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 and M. pneumoniae IgG/IgM Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INMC-425H7
Basic UDI-DI: B-INMC-425H7
Reference: INMC-425
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Astrovirus Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IAS-ACO607X7
Basic UDI-DI: B-IAS-ACO607X7
Reference: IAS-ACO607
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IAD-ACO607NA
Basic UDI-DI: B-IAD-ACO607NA
Reference: IAD-ACO607
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: VidaQuick Biotech S.L.
Last updated: 29.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details