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Influenza A/B+H1N1 Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IINA-525EE
Basic UDI-DI: B-IINA-525EE
Reference: IINA-525
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IIN-501(AT)A3
Basic UDI-DI: B-IIN-501(AT)A3
Reference: IIN-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

HMPV Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHMPV-ACO502UU
Basic UDI-DI: B-IHMPV-ACO502UU
Reference: IHMPV-ACO502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFLA-502BM
Basic UDI-DI: B-IFLA-502BM
Reference: IFLA-502
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFLA-501BK
Basic UDI-DI: B-IFLA-501BK
Reference: IFLA-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

H&W SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

123143-01-102 123143-02-102 123143-05-102 123143-20-102

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167891631
Basic UDI-DI: 697416789100NQ
Reference: HW-5combo-2025-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 1 · Rev. 1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 24.07.2026 09:59

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

Dengue NS1 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IDES-R4026U
Basic UDI-DI: B-IDES-R4026U
Reference: IDES-R402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IDEN-R4024T
Basic UDI-DI: B-IDEN-R4024T
Reference: IDEN-R402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IDEN-402C2
Basic UDI-DI: B-IDEN-402C2
Reference: IDEN-402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

06977775222316

Influenza A+B Antigen Combo Rapid Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: 06977775222316
Basic UDI-DI: 693869768062S6
Reference: 8062C01
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Belgium
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IFL-A502

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412616787
Basic UDI-DI: 697241261IFL-A502JL
Reference: IFL-A502-25
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IRS-502

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412615711
Basic UDI-DI: 697241261IRS-502JZ
Reference: IRS-502-07
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IFL-502

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412614301
Basic UDI-DI: 697241261IFL-502BQ
Reference: IFL-502-25
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

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: 06972412619269
Basic UDI-DI: 697241261IRS-502JZ
Reference: IRS-502-25
EMDN: W0105099002
EMDN description: RSV - 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

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412616879
Basic UDI-DI: 697241261IFL-A502JL
Reference: IFL-A502-07
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - 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

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618088
Basic UDI-DI: 697241261IFL-502BQ
Reference: IFL-502-07
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - 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

Cryptosporidium and Giardia lamblia Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICGC-62598
Basic UDI-DI: B-ICGC-62598
Reference: ICGC-625
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 07:29

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A+B Test (Swab/Nasal Aspirate)

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: D-SW02-FLAB(PRO)CM
Basic UDI-DI: B-SW02-FLAB(PRO)CM
Reference: SW02-FLAB(PRO)
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A (H5) Ag Rapid Test Cassette (Swab)

GCFLU(AH5)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(AH5)-502aOGKU
Basic UDI-DI: B-GCFLU(AH5)-502aOGKU
Reference: GCFLU(AH5)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A (H5) Ag Rapid Test Cassette (Swab)

GCFLU(AH5)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(AH5)-502aHGK7
Basic UDI-DI: B-GCFLU(AH5)-502aHGK7
Reference: GCFLU(AH5)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details