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446 device results listed.

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CerTest SARS-CoV-2+ Flu A + Flu B

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440218135
Basic UDI-DI: 84354402IDXRESPB_SS8J
Reference: SS872001PCC
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:52

Manufacturer products View details

CerTest SARS-CoV-2+ Flu A + Flu B + RSV

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440258728
Basic UDI-DI: 84354402IDXRESPB_SV8Q
Reference: SV862001P
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:52

Manufacturer products View details

CerTest SARS-CoV-2+ Flu A + Flu B + RSV

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440218142
Basic UDI-DI: 84354402IDXRESPB_SV8Q
Reference: SV862001PCC
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:52

Manufacturer products View details

SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ISIC-ACO50283
Basic UDI-DI: B-ISIC-ACO50283
Reference: ISIC-ACO502
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: France
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

10743816001553

Status COVID-19/Flu

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

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816001553
Basic UDI-DI: B-10743816001553
Reference: 33225
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

ViraxClear Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo)

Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: 06974246461076
Basic UDI-DI: B-06974246461076
Reference: FCRA-6052
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804838805
Basic UDI-DI: B-06952804838805
Reference: MI-S46001
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

06930317808522

20 tests (A)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317808522
Basic UDI-DI: B-06930317808522
Reference: DNK-2104-1
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801356

20 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801356
Basic UDI-DI: B-06930317801356
Reference: DNK-2104-1
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card

1N44C5

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963719935
Basic UDI-DI: B-06921963719935
Reference: 1N44C5
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - 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/Flu A+B/RSV Antigen Test Card

1N45C5-1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963715982
Basic UDI-DI: B-06921963715982
Reference: 1N45C5-1
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

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

1N41C5-25

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963715913
Basic UDI-DI: B-06921963715913
Reference: 1N41C5-25
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card

1N45C5

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963715364
Basic UDI-DI: B-06921963715364
Reference: 1N45C5
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

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

1N41C5-27

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963715357
Basic UDI-DI: B-06921963715357
Reference: 1N41C5-27
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A&B/SARS-CoV-2 Antigen Combo Test

RVC-532b-25M

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

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910666
Basic UDI-DI: 69798909110004CK
Reference: RVC-532b-25M
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

8-in-1 Respiratory Antigen Combo Rapid Test

RVC-585b-25M

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

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910659
Basic UDI-DI: 69798909110057D8
Reference: RVC-585b-25M
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

10-in-1 Respiratory Antigen Combo Rapid Test

RVC-5105a-25M

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

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910642
Basic UDI-DI: 69798909110058DA
Reference: RVC-5105a-25M
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303045201-01;303045201-05;303045201-20;303045201-25;303045201-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612031
Basic UDI-DI: 0697241261IRS-RA5229P
Reference: 303045201-01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303041901

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611478
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901-25
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

Trichomonas vaginalis/Gardnerella vaginalis/Candida albicans Combo Rapid Test

Trichomonas vaginalis/Gardnerella vaginalis/ Candida albicans Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ITGC-535J7
Basic UDI-DI: B-ITGC-535J7
Reference: ITGC-535
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details