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100 device results listed.

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Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873140118
Basic UDI-DI: 697387314DH3SQ
Reference: DH3-192
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873140101
Basic UDI-DI: 697387314DH3SQ
Reference: DH3-072
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873140026
Basic UDI-DI: 697387314DH3SQ
Reference: DH3-096
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873140019
Basic UDI-DI: 697387314DH3SQ
Reference: DH3-048
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV 16 18/45 Genotype Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500129
Basic UDI-DI: 54200455DIAGAPTHPVGTVK
Reference: 303236
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731523
Basic UDI-DI: 69557927S3057E000001SS
Reference: S3057E-48
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731288
Basic UDI-DI: B-06955792731288
Reference: S3108E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731271
Basic UDI-DI: B-06955792731271
Reference: S3108E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731219
Basic UDI-DI: B-06955792731219
Reference: S3057E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731073
Basic UDI-DI: B-06955792731073
Reference: S3027E-48
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731059
Basic UDI-DI: B-06955792731059
Reference: S3027E-24
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

06955792730960

Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730960
Basic UDI-DI: B-06955792730960
Reference: S3017E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730953
Basic UDI-DI: B-06955792730953
Reference: S3017E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

06955792730946

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

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730946
Basic UDI-DI: B-06955792730946
Reference: S3019E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730939
Basic UDI-DI: B-06955792730939
Reference: S3019E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004473
Basic UDI-DI: B-06950996004473
Reference: 2HPV18A11
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

06937044500859

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Ningbo HEALTH Gene Technologies Co., LTD.
Manufacturer SRN: CN-MF-000002278
UDI-DI: 06937044500859
Basic UDI-DI: B-06937044500859
Reference: 1060015
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

06937044500842

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Ningbo HEALTH Gene Technologies Co., LTD.
Manufacturer SRN: CN-MF-000002278
UDI-DI: 06937044500842
Basic UDI-DI: B-06937044500842
Reference: 1060136
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo HPV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570541
Basic UDI-DI: B-04719878570541
Reference: PCRAD1104/ PCRAD1114
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.06.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV 16 18/45 Genotype Assay Calibrators Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500136
Basic UDI-DI: 54200455DIAGAPTHPVGTVK
Reference: 303235
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 16.06.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details