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CerTest Influenza A+B+RSV+Adeno Resp

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200888
Basic UDI-DI: 84354402IDXRESPB_ZV9D
Reference: ZV862001P
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 16:41

Manufacturer products View details

CerTest Influenza A+B

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200864
Basic UDI-DI: 84354402IDXRESPB_ZDT
Reference: Z882001PC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 16:41

Manufacturer products View details

CerTest Adenovirus Resp.

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200802
Basic UDI-DI: 84354402IDXRESPB_AP6N
Reference: AP820001PC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 16:41

Manufacturer products View details

CerTest RSV

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440200789
Basic UDI-DI: 84354402IDXRESPB_RV8M
Reference: RV820001PC
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 16:41

Manufacturer products View details

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

Cassette

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

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062713869
Basic UDI-DI: 69520627J013L5
Reference: COVAg1NNO3-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 05.08.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgM Rapid Test

ICHI4002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICHI400TJ
Basic UDI-DI: B-ICHI400TJ
Reference: ICHI4002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 05.08.2026 15:32

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgM/IgG Ab Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140419
Basic UDI-DI: B-06958982140419
Reference: AB330-20
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Ag Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle useSterile

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140402
Basic UDI-DI: B-06958982140402
Reference: AB331-20
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Ag Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140235
Basic UDI-DI: B-06958982140235
Reference: AH40-20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Estonia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B+RSV Combo Ag Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140150
Basic UDI-DI: B-06958982140150
Reference: AB340-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Czechia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B+COVID-19/RSV Combo Ag Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140143
Basic UDI-DI: B-06958982140143
Reference: ABC292-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Czechia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B/RSV/ADV Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140136
Basic UDI-DI: B-06958982140136
Reference: AB350-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Czechia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B+COVID-19 Combo Ag Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140129
Basic UDI-DI: B-06958982140129
Reference: AB120-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Czechia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

Atlas

8.04.86.0.0025

IVD generalIVDDOn the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04262408511946
Basic UDI-DI: B-04262408511946
Reference: 8.04.86.0.0025
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:43

Manufacturer products View details

Rapid Influenza A + B Antigen Test Card

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163316059
Basic UDI-DI: B-04260163316059
Reference: 07FLUA020AG
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:42

Manufacturer products View details

Rapid Influenza A Antigen Test Card

IVD generalNot specifiedOn the marketSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163316042
Basic UDI-DI: B-04260163316042
Reference: 07FLUA020
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:40

Manufacturer products View details

Dengue NS1 Antigen Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163316028
Basic UDI-DI: B-04260163316028
Reference: 07DEN0
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:40

Manufacturer products View details

Rapid SARS-CoV-2 Influenza A+B Antigen Duo Test Card

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315984
Basic UDI-DI: B-04260163315984
Reference: 07AG6020FL
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:40

Manufacturer products View details

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

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

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062713883
Basic UDI-DI: 69520627J013L5
Reference: COVAg1NNO3-3
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CerTest Influenza A+B

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440259718
Basic UDI-DI: 84354402IDXRESPB_ZDT
Reference: Z882001P
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:55

Manufacturer products View details