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138 device results listed.

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VSCD10ST01

IVD generalIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548251046
Basic UDI-DI: B-08683548251046
Reference: VSCD10ST
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 19:53

Manufacturer products View details

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

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISIR-535(AT)47
Basic UDI-DI: B-ISIR-535(AT)47
Reference: ISIR-535
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISIC-502(AT)P3
Basic UDI-DI: B-ISIC-502(AT)P3
Reference: ISIC-502
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ISIC-ACOR525JU
Basic UDI-DI: B-ISIC-ACOR525JU
Reference: ISIC-ACOR525
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

RSV and SARS-CoV-2 Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IRSC-ACO502EC
Basic UDI-DI: B-IRSC-ACO502EC
Reference: IRSC-ACO502
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-ISIR-ACOR535VQ

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

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ISIR-ACOR535VQ
Basic UDI-DI: B-ISIR-ACOR535VQ
Reference: ISIR-ACOR535
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

D-ICIC-ACOR5253C

COVID-19 and Influenza A+B Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICIC-ACOR5253C
Basic UDI-DI: B-ICIC-ACOR5253C
Reference: ICIC-ACOR525
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

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: 08435440214960
Basic UDI-DI: 84354402IDXRESPB_SS8J
Reference: SS872001PC
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 16:41

Manufacturer products View details

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: 08435440258711
Basic UDI-DI: 84354402IDXRESPB_SS8J
Reference: SS872001P
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:53

Manufacturer products View details

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

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

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/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/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

Συνδυαστικό τεστ ταχείας ανίχνευσης αντιγόνου του COVID-19 και της Ινφλουέντζας A+B Για αυτοδοκιμή

COVID-19 & Influenza A+B Antigen Combo Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: 06974246461144
Basic UDI-DI: B-06974246461144
Reference: FCO-6032H
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Share info GmbH
Last updated: 28.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303034002

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612277
Basic UDI-DI: 0697241261IRS-CF5225M
Reference: 303034002-05
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 22.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613632
Basic UDI-DI: 0697241261IRS-CF5225M
Reference: 303034002-01
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details