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309 device results listed.

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High-risk HPV genotyping real-time PCR detection kit

PV02-1Y24

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKit

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689627190
Basic UDI-DI: B-06974689627190
Reference: 13787-2
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

HPV nucleic acid real-time PCR detection kit

PV01-1Y32

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689627046
Basic UDI-DI: B-06974689627046
Reference: 13778-2
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

High-risk HPV genotyping real-time PCR detection kit

PV02-2Y24

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626360
Basic UDI-DI: B-06974689626360
Reference: "Model: PV02-2Y24; Specification: 24 Tests Model: PV02-1Y24; Specification: 24 Tests"
EMDN: W0105041099
EMDN description: HPV REAGENTS - OTHER
First on market country: Finland
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

HPV nucleic acid real-time PCR detection kit

PV01-2Y32

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626056
Basic UDI-DI: B-06974689626056
Reference: 13778-1
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892497
Basic UDI-DI: B-06974674892497
Reference: 18-01-0009
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit(PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892480
Basic UDI-DI: B-06974674892480
Reference: 18-01-0008
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565684

24 samples/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565684
Basic UDI-DI: B-06974541565684
Reference: PR2026-HP04
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565677

8 samples/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565677
Basic UDI-DI: B-06974541565677
Reference: PR2026-HP04
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Cyprus
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012924

PCR-based HPV Test and 1618 Genotyping Test Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012924
Basic UDI-DI: B-06974323012924
Reference: ID021
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papilloma Virus (HPV) Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910674
Basic UDI-DI: B-06974238910674
Reference: HHPV071G
EMDN: W0105041001
EMDN description: HPV ANTIGEN / ANTIBODIES
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing)

HPV002-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870378
Basic UDI-DI: B-06974081870378
Reference: HPV002-48
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for High-risk Human Papillomavirus (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870309
Basic UDI-DI: B-06974081870309
Reference: HPV001
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

High Risk Human Papillomavirus (HPV) Genotyping System

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149074
Basic UDI-DI: B-06973873149074
Reference: HPVS02
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Portugal
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus（HPV）DNA Diagnostic Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: 3D Biomedicine Science & Technology Co., Limited
Manufacturer SRN: CN-MF-000020934
UDI-DI: 06973685471318
Basic UDI-DI: B-06973685471318
Reference: 3000000000366
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Greece
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742831

100 Tests/kit

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742831
Basic UDI-DI: B-06973316742831
Reference: R151013
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742824

50 Tests/kit

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742824
Basic UDI-DI: B-06973316742824
Reference: R151012
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

Logilet HPV Panel

VD4011

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739214
Basic UDI-DI: B-06973315739214
Reference: VD4011
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Logilet Hr-HPV Panel

DHPV01M

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739221
Basic UDI-DI: B-06973315739221
Reference: DHPV01M
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® Screening test for Cervical Pre-cancer and Cancer

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850426
Basic UDI-DI: B-06973181850426
Reference: 500140
EMDN: W0105041001
EMDN description: HPV ANTIGEN / ANTIBODIES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450886

32tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450886
Basic UDI-DI: B-06972221450886
Reference: 32tests/kit
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details