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D-TD-HNVC-CED-02X4

Multiple-type Respiratory Pathogen Nucleic Acid Kit (Fluorescent PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Henan Vacure Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023292
UDI-DI: D-TD-HNVC-CED-02X4
Basic UDI-DI: B-TD-HNVC-CED-02X4
Reference: /
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-574J

Influenza A/B & RSV Antigen Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-574J
Basic UDI-DI: B-TD-HNKX-CED-574J
Reference: /
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cwingene STI Multiplex Pro Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST1702E3
Basic UDI-DI: B-ST1702E3
Reference: ST170(21V, 21Y, 21V-1, 21Y-1, 21V-2, 21Y-2, 21V-3, 21Y-3, 22U, 22X, 22U-1, 22X-1, 22U-2, 22X-2, 22U-3, 22X-3)
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene STI Multiplex Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST11MZ
Basic UDI-DI: B-ST11MZ
Reference: ST11021V, ST11022U, ST13021W, ST13022U, ST14021X, ST14022X, ST14023W, ST15023P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST01MW
Basic UDI-DI: B-ST01MW
Reference: ST01021V, ST01022U
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel Pro Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP2602CC
Basic UDI-DI: B-RP2602CC
Reference: RP26021V, RP26021Y, RP26021V-1, RP26021Y-1, RP26022U, RP26022X, RP26022U-1, RP26022X-1
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel 21 Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP23021VA5
Basic UDI-DI: B-RP23021VA5
Reference: RP23021V
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP13MA
Basic UDI-DI: B-RP13MA
Reference: RP13021W, RP13022S, RP14021W, RP16023P, RP19023P RP14022U,
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 2

RP2-P7-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP2-P7-10YM
Basic UDI-DI: B-RP2-P7-10YM
Reference: RP2-P7-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 1.0

RP1-P10-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP1-P10-10NG
Basic UDI-DI: B-RP1-P10-10NG
Reference: RP1-P10-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene SARS-CoV-2 & Influenza A/B Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP11M6
Basic UDI-DI: B-RP11M6
Reference: RP11021X, RP11022X, RP11023W
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Influenza A/B and RSV Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP03M7
Basic UDI-DI: B-RP03M7
Reference: RP03021X, RP03022X, RP03023W
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Panel 1.1

RP-P10-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-RP-P10-10XX
Basic UDI-DI: B-RP-P10-10XX
Reference: RP-P10-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal pH Rapid Test Strip (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGVPH-501aLF
Basic UDI-DI: B-OGVPH-501aLF
Reference: VPH-501a
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

LeoNext PP Library Prep Kit

NGS3104

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-NGS3104WS
Basic UDI-DI: B-NGS3104WS
Reference: NGS3104-01 NGS3104-02 NGS3104-03
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90508ZM

Influenza & SARS-CoV-2 Antigen Combo 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-K90508ZM
Basic UDI-DI: B-K90508ZM
Reference: /
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-016PC

Procalcitonin (PCT) & Interleukin-6 (IL-6) Combo Test Kit (Fluorescence 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-K90411-016PC
Basic UDI-DI: B-K90411-016PC
Reference: /
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-015PA

Serum Amyloid A (SAA) & Full C-reactive protein (CRP) Combo Test Kit (Fluorescence 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-K90411-015PA
Basic UDI-DI: B-K90411-015PA
Reference: /
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-014P8

Procalcitonin (PCT) & Full C-reactive protein (CRP) Combo Test Kit (Fluorescence 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-K90411-014P8
Basic UDI-DI: B-K90411-014P8
Reference: /
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

InfectCheck SARS-CoV-2/RSV/FluA/FluB

SARS-CoV-2/RSV/ FluA/ FluB Antigen 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-K12-RVPanel4CU
Basic UDI-DI: B-K12-RVPanel4CU
Reference: 811028/ K12-RVPanel4
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details