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211 device results listed.

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Influenza A & B Ag Rapid Test Strip (Swab)

GCFLU(A/B)-501a

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)-501aAB
Basic UDI-DI: B-GCFLU(A/B)-501aAB
Reference: GCFLU(A/B)-501a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Ag Rapid Test Strip (Swab)

GCFLU(A)-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A)-501aWQ
Basic UDI-DI: B-GCFLU(A)-501aWQ
Reference: GCFLU(A)-501a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B-Q Real Time PCR Kit

G2M706021

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M706021F5
Basic UDI-DI: B-G2M706021F5
Reference: G2M706021, G2M706021R
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FLU-B22bGV
Basic UDI-DI: B-FLU-B22bGV
Reference: FLU-B22b
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Antigen Rapid Test

FLU-522b

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-FLU-522bE9
Basic UDI-DI: B-FLU-522bE9
Reference: FLU-522b
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR006GF
Basic UDI-DI: B-CNMF000054349CR006GF
Reference: CR006
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Chemtrue ®® Influenza A+B Antigen Combo Rapid Test (Lateral Flow)

Influenza A+B Antigen Combo Rapid Test (Lateral Flow)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180720007M2
Basic UDI-DI: B-CNM0000180720007M2
Reference: 8010C
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Covid-19 + Influenza A/B + RSV Combo Rapid Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000020377
UDI-DI: D-CIRC-02TX
Basic UDI-DI: B-CIRC-02TX
Reference: CIRC-02
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 05:05

Manufacturer products Authorised representative products Authorised representative actors View details

Covid-19 + Influenza A/B Combo Rapid Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000020377
UDI-DI: D-CIC-025X
Basic UDI-DI: B-CIC-025X
Reference: CIC-02
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 05:05

Manufacturer products Authorised representative products Authorised representative actors View details

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

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A247V8
Basic UDI-DI: B-ABT-IDT-A247V8
Reference: ABT-IDT-A247
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AIAH501DC9SA

AIAH501D-AHG48E; AIAH501D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AIAH501DC9SA
Basic UDI-DI: B-81649002AIAH501DC9SA
Reference: AIAH501D-AHG48E; AIAH501D-AHG96E
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: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AFAB03D6VFC

AFAB03D-AHG48E; AFAB03D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AFAB03D6VFC
Basic UDI-DI: B-81649002AFAB03D6VFC
Reference: AFAB03D-AHG48E; AFAB03D-AHG96E
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: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AFAB038S9K

AFAB03-AHG48E; AFAB03-AHG96E; AFAB03D-AHG48E; AFAB03D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AFAB038S9K
Basic UDI-DI: B-81649002AFAB038S9K
Reference: AFAB03-AHG48E; AFAB03-AHG96E; AFAB03D-AHG48E; AFAB03D-AHG96E
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: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AFAB018N8X

AFAB01-AHG48E; AFAB01-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AFAB018N8X
Basic UDI-DI: B-81649002AFAB018N8X
Reference: AFAB01-AHG48E; AFAB01-AHG96E
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: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-808051Q8

Flu A & Flu B Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808051Q8
Basic UDI-DI: B-808051Q8
Reference: 808051
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808050Q6

Flu B Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808050Q6
Basic UDI-DI: B-808050Q6
Reference: 808050
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808049QM

Flu A Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808049QM
Basic UDI-DI: B-808049QM
Reference: 808049
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

16974198353013

FLU A+B Antigen combo Rapid Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Higene Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000029811
UDI-DI: 16974198353013
Basic UDI-DI: B-16974198353013
Reference: nFLuAG
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A+B Antigen Rapid Test Device

P212102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600057
Basic UDI-DI: B-16972698600057
Reference: P212102
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A+B Antigen Rapid Test

P211002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600026
Basic UDI-DI: B-16972698600026
Reference: P211002
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details