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211 device results listed.

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Influenza A/B Rapid Test Kit

A02105002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861683559
Basic UDI-DI: B-06973861683559
Reference: A02105002
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:41

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® Influenza A/ B Combo Antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850471
Basic UDI-DI: B-06973181850471
Reference: 500320
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® Influenza A Antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850464
Basic UDI-DI: B-06973181850464
Reference: 500310
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303051

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611256
Basic UDI-DI: B-06972412611256
Reference: 303051
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

06971100211372

Type A, Type B, Type C

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: 06971100211372
Basic UDI-DI: B-06971100211372
Reference: A1A324020007，A1A324020019，A1A324020031
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Flu Neo 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815005719
Basic UDI-DI: B-04987815005719
Reference: CAFL0571
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 06.07.2026 08:10

Manufacturer products Authorised representative products Authorised representative actors View details

Toda Infludiag A&B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309510125
Basic UDI-DI: B-03760309510125
Reference: 1061
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

INFLUENZATOP BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678588902
Basic UDI-DI: B-03532678588902
Reference: SW40002
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

VIRAPID® INFLUENZA A/INFLUENZA B Ag FIA

VRF004

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290791
Basic UDI-DI: 843661029VRF00401R8
Reference: VRF004
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

Simple Flu A+B

9.080.XX.YYY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003214
Basic UDI-DI: 84295779080XZ
Reference: 9.080.020.46.000
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

GenSure Flu A+B Ag Rapid Test

Flu A+B Ag Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230302
Basic UDI-DI: 697683823P201800F4
Reference: P2018C01
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Cyprus
Safety summary (SSCP/SSP): GS/TD-EU-P2018-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

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

05902643958456

Influenza A+B kas. 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958456
Basic UDI-DI: 59026439BRT329JU
Reference: 1-329-K020
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

06970895475983

Influenza A H1N1(2009) Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895475983
Basic UDI-DI: B-06970895475983
Reference: R26701T2048
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Greece
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details

06970895474214

Influenza A&B Rapid Test Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895474214
Basic UDI-DI: B-06970895474214
Reference: R501T020B0C0
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

06970895474108

Influenza A&B Rapid Test Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895474108
Basic UDI-DI: B-06970895474108
Reference: R084T020B0C0
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Influenza A+B Cassette (Swab/Nasal Aspirate)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432269
Basic UDI-DI: B-06970581432269
Reference: ABT-IDT-B247
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Antigen Rapid Test (Colloidal Gold)

VILFA-20

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080963
Basic UDI-DI: B-06970514080963
Reference: VILFA-20
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Antigen Rapid Test (Colloidal Gold)

VILFA-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080956
Basic UDI-DI: B-06970514080956
Reference: VILFA-01
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Rapid Test

FLU-S23M

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827021
Basic UDI-DI: B-06952804827021
Reference: FLU-S23M
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Rapid Test Device

A46071120,A46071220

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804809478
Basic UDI-DI: 69528048A46071028
Reference: A46071
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details