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06975447582157

12 reactions/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447582157
Basic UDI-DI: B-06975447582157
Reference: 106-0066-01
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

06975447582140

12 reactions/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447582140
Basic UDI-DI: B-06975447582140
Reference: 106-0064-01
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

06975447582133

12 reactions/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447582133
Basic UDI-DI: B-06975447582133
Reference: 106-0062-01
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

VIUICK

Diagnostic Kit for Human Papilloma Virus 14 High-Risk Genotyping DNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000017369
UDI-DI: 06975400320154
Basic UDI-DI: B-06975400320154
Reference: 48 Tests/Kit
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:31

Manufacturer products Authorised representative products Authorised representative actors View details

HPV Genotyping Kit

Specification C: 8 tests/strip, 24 tests/box

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou KingCreate Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000032033
UDI-DI: 06974987420073
Basic UDI-DI: B-06974987420073
Reference: KS624-HPVC24
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

HPV Genotyping Kit

Specification B: 8 tests/strip, 24 tests/box

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou KingCreate Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000032033
UDI-DI: 06974987420066
Basic UDI-DI: B-06974987420066
Reference: KS624-HPVB24
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

HPV Genotyping Kit

Specification A: 1 test/tube, 24 tests/box

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou KingCreate Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000032033
UDI-DI: 06974987420059
Basic UDI-DI: B-06974987420059
Reference: KS624-HPVA24
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) 31 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Biotron Technology Co., Ltd.
Manufacturer SRN: CN-MF-000055334
UDI-DI: 06974956160603
Basic UDI-DI: B-06974956160603
Reference: BC1042
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) 15 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Biotron Technology Co., Ltd.
Manufacturer SRN: CN-MF-000055334
UDI-DI: 06974956160597
Basic UDI-DI: B-06974956160597
Reference: BB9021
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) E6/E7 mRNA Genotyping Detection Kit (Fluorescent PCR Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Biotron Technology Co., Ltd.
Manufacturer SRN: CN-MF-000055334
UDI-DI: 06974956160580
Basic UDI-DI: B-06974956160580
Reference: BQ3022
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) E6/E7 mRNA Genotyping Detection Kit (Fluorescent PCR Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Biotron Technology Co., Ltd.
Manufacturer SRN: CN-MF-000055334
UDI-DI: 06974956160573
Basic UDI-DI: B-06974956160573
Reference: BQ3021
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) 15 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Biotron Technology Co., Ltd.
Manufacturer SRN: CN-MF-000055334
UDI-DI: 06974956160221
Basic UDI-DI: B-06974956160221
Reference: BB9011
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) 31 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Biotron Technology Co., Ltd.
Manufacturer SRN: CN-MF-000055334
UDI-DI: 06974956160214
Basic UDI-DI: B-06974956160214
Reference: BC1041
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

14 High-Risk HPV with 16/18 Genotyping Test Kit（Fluorescence PCR）

50 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366372
Basic UDI-DI: B-06974849366372
Reference: HWTS-CC007A
EMDN: W0105041099
EMDN description: HPV REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

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