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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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CerTest Astrovirus

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440207344
Basic UDI-DI: 84354402IDXGASTROB_AT6W
Reference: AT820001VCC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:55

Manufacturer products View details

Influenza A+B Antigen Rapid Test

Influenza A+B Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FLU-B22bGV
Basic UDI-DI: B-FLU-B22bGV
Reference: FLU-B22b
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Antigen Rapid Test

FLU-522b

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-FLU-522bE9
Basic UDI-DI: B-FLU-522bE9
Reference: FLU-522b
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-FIMF16823COV7S67

Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823COV7S67
Basic UDI-DI: B-FIMF16823COV7S67
Reference: COV-07-S
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

D-FIMF16823COV06SEQ

Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal Swab)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823COV06SEQ
Basic UDI-DI: B-FIMF16823COV06SEQ
Reference: COV-06-S
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

D-FIMF16823COV062STG

Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823COV062STG
Basic UDI-DI: B-FIMF16823COV062STG
Reference: COV-062-S
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Slovenia
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

D-FIMF16823COV061STD

Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823COV061STD
Basic UDI-DI: B-FIMF16823COV061STD
Reference: COV-061-S
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

D-FIMF16823CLACOV19AGVIAB

Clarity COVID-19 Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823CLACOV19AGVIAB
Basic UDI-DI: B-FIMF16823CLACOV19AGVIAB
Reference: CLA-COV19AG-VIS
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

D-FIMF168237575STREPAxxGG

Strep A test kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF168237575STREPAxxGG
Basic UDI-DI: B-FIMF168237575STREPAxxGG
Reference: 75-75STREPA-xx
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Sweden
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

D-FIMF16823102261KZ

Sienna COVID-19 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823102261KZ
Basic UDI-DI: B-FIMF16823102261KZ
Reference: 102261
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

D-FIMF16823102251KW

Sienna COVID-19 Antigen Rapid Test Cassette (Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823102251KW
Basic UDI-DI: B-FIMF16823102251KW
Reference: 102251
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

D-FIMF1682310224XN7

Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF1682310224XN7
Basic UDI-DI: B-FIMF1682310224XN7
Reference: 10224X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 13.07.2026 21:32

Manufacturer products View details

SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)

FCCOV-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCCOV-502aHG3B
Basic UDI-DI: B-FCCOV-502aHG3B
Reference: FCCOV-502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)

SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCCOV-502a3D
Basic UDI-DI: B-FCCOV-502a3D
Reference: FCCOV-502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Flowflex Dengue NS1 Ag FIA Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-F131-10615-201RJ
Basic UDI-DI: B-F131-10615-201RJ
Reference: F131-10615-201
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

FIAflex Dengue NS1 Ag FIA Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-F131-10611-201Q6
Basic UDI-DI: B-F131-10611-201Q6
Reference: F131-10611-201
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM and NS1 Combo Rapid Test

DENC-435a

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-DENC-435aWK
Basic UDI-DI: B-DENC-435aWK
Reference: DENC-435a
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test

DEN-422a

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-DEN-422a68
Basic UDI-DI: B-DEN-422a68
Reference: DEN-422a
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag Rapid Test

DEN-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-DEN-402b5Y
Basic UDI-DI: B-DEN-402b5Y
Reference: DEN-402b
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Rapid Test

Dengue NS1 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-DEAG-D02bTV
Basic UDI-DI: B-DEAG-D02bTV
Reference: DEAG-D02b
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:24

Manufacturer products Authorised representative products Authorised representative actors View details