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385 device results listed.

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Aptima HPV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509573
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 303093
EMDN: W0105041002
EMDN description: SCREENING 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

Aptima HPV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509580
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 303093
EMDN: W0105041002
EMDN description: SCREENING 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 (26 Genotypes) Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731684
Basic UDI-DI: B-06955792731684
Reference: S3068E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Greece
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 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

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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

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06955792731226

Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731226
Basic UDI-DI: B-06955792731226
Reference: S3057E
EMDN: W0105041099
EMDN description: HPV REAGENTS - OTHER
First on market country: Belgium
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

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06955792731042

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

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731042
Basic UDI-DI: B-06955792731042
Reference: S3031E
EMDN: W0105041002
EMDN description: SCREENING 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

15 High-risk 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: 06955792731035
Basic UDI-DI: B-06955792731035
Reference: S3031E
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

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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

15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

S3360E-12-P

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730632
Basic UDI-DI: B-06955792730632
Reference: S3360E-12-P
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

S3360E-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730625
Basic UDI-DI: B-06955792730625
Reference: S3360E-48
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Akso HPV Real-time PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751192
Basic UDI-DI: 695441479704KN
Reference: RT6003
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso HPV Real-time PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751185
Basic UDI-DI: 695441479704KN
Reference: RT6003
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details