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22.09.2026 04:45

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211 device results listed.

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One Step Influenza B Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W73-CH7X
Basic UDI-DI: B-W73-CH7X
Reference: W73-CH
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Influenza A Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W72-SH98
Basic UDI-DI: B-W72-SH98
Reference: W72-SH
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Influenza A Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W72-CH7Q
Basic UDI-DI: B-W72-CH7Q
Reference: W72-CH
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Influenza A&B Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W71-SH8Z
Basic UDI-DI: B-W71-SH8Z
Reference: W71-SH
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Influenza A&B Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W71-CH7H
Basic UDI-DI: B-W71-CH7H
Reference: W71-CH
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Rapid Test Kit

SC10101W-25T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC10101W-25TUG
Basic UDI-DI: B-SC10101W-25TUG
Reference: SC10101W-25T
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

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Influenza A&B Rapid Test Kit

SC10101W-50T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC10101W-50TUG
Basic UDI-DI: B-SC10101W-50TUG
Reference: SC10101W-50T
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

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Influenza A&B Rapid Test Kit

SC10101W-1T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC10101W-1TYA
Basic UDI-DI: B-SC10101W-1TYA
Reference: SC10101W-1T
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Rapid Test Kit

SC10101W-20T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-SC10101W-20TTZ
Basic UDI-DI: B-SC10101W-20TTZ
Reference: .SC10101W-20T
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Antigen Test kit(Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90507ZK
Basic UDI-DI: B-K90507ZK
Reference: /
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

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50 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-50tBT
Basic UDI-DI: B-IVD53-02-50tBT
Reference: IVD53-02-50t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

20 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-20tBC
Basic UDI-DI: B-IVD53-02-20tBC
Reference: IVD53-02-20t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

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1 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-1tH5
Basic UDI-DI: B-IVD53-02-1tH5
Reference: IVD53-02-1t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

10 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-10tB7
Basic UDI-DI: B-IVD53-02-10tB7
Reference: IVD53-02-10t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

IIN-501

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IIN-501SC
Basic UDI-DI: B-IIN-501SC
Reference: IIN-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)

Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD148XS
Basic UDI-DI: B-GKPD148XS
Reference: GKPD148
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Cassette (Swab)

GCFLU(A/B)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(A/B)-502aHG63
Basic UDI-DI: B-GCFLU(A/B)-502aHG63
Reference: GCFLU(A/B)-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: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Cassette (Swab)

GCFLU(A/B)-502Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(A/B)-502CaHGN5
Basic UDI-DI: B-GCFLU(A/B)-502CaHGN5
Reference: GCFLU(A/B)-502Ca
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: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Cassette (Swab)

GCFLU(A/B)-502a, GCFLU(A/B)-502Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A/B)-5024L
Basic UDI-DI: B-GCFLU(A/B)-5024L
Reference: GCFLU(A/B)-502a，GCFLU(A/B)-502Ca
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: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Strip (Swab)

GCFLU(A/B)-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(A/B)-501aHG5U
Basic UDI-DI: B-GCFLU(A/B)-501aHG5U
Reference: GCFLU(A/B)-501a
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: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details