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59 device results listed.

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Allplex™ HPV HR Detection

Allplex™ HPV HR Detection

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102626
Basic UDI-DI: 924010HP30370GH
Reference: HP30371Z
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV HR Detection

Allplex™ HPV HR Detection

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102619
Basic UDI-DI: 924010HP30370GH
Reference: HP30370X
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Hr-HPV

M10-HPV-02

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111721991
Basic UDI-DI: 88001117IPCA01MA18XR
Reference: 11HPV20A
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors View details

UniPatogen CerviPan HPV qPCR Screening Kit

UniPatogen CerviPan HPV qPCR Screening Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000019285
UDI-DI: 08699863071740
Basic UDI-DI: 869986307PHCPNZM
Reference: PHCPN-250
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 01.07.2026 02:57

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UniPatogen CerviPan HPV qPCR Screening Kit

UniPatogen CerviPan HPV qPCR Screening Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000019285
UDI-DI: 08699863071733
Basic UDI-DI: 869986307PHCPNZM
Reference: PHCPN-100
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 01.07.2026 02:57

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UniPatogen CerviPan HPV qPCR Screening Kit

UniPatogen CerviPan HPV qPCR Screening Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000019285
UDI-DI: 08699863071726
Basic UDI-DI: 869986307PHCPNZM
Reference: PHCPN-50
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 01.07.2026 02:57

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UniPatogen CerviPan HPV qPCR Screening Kit

UniPatogen CerviPan HPV qPCR Screening Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000019285
UDI-DI: 08699863071672
Basic UDI-DI: 869986307PHCPNZM
Reference: PHCPN-1000
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 01.07.2026 02:57

Manufacturer products View details

UniPatogen CerviPan HPV qPCR Screening Kit

UniPatogen CerviPan HPV qPCR Screening Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000019285
UDI-DI: 08699863071665
Basic UDI-DI: 869986307PHCPNZM
Reference: PHCPN-500
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 01.07.2026 02:57

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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: 15420045509559
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 302929
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: 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

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)

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

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus 16 & 18 Nucleic Acid Detection Kit (PCR-Fluorescent Probe)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Triplex International Biosciences (China) Co., LTD.
Manufacturer SRN: CN-MF-000001097
UDI-DI: 06950917910579
Basic UDI-DI: B-06950917910579
Reference: C011938
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

13 Types of High-Risk Human Papillomavirus Nucleic Acid Detection Kit (PCR-Fluorescent Probe）

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Triplex International Biosciences (China) Co., LTD.
Manufacturer SRN: CN-MF-000001097
UDI-DI: 06950917910562
Basic UDI-DI: B-06950917910562
Reference: C011937
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

Papilloplex® HR-HPV DNA Kit

-

IVD generalNot specifiedOn the market

Manufacturer: GeneFirst Limited
Manufacturer SRN: GB-MF-000025181
UDI-DI: 05060670520036
Basic UDI-DI: B-05060670520036
Reference: MPAHPV006
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

Papilloplex® HR-HPV mRNA Kit

-

IVD generalNot specifiedOn the market

Manufacturer: GeneFirst Limited
Manufacturer SRN: GB-MF-000025181
UDI-DI: 05060670520029
Basic UDI-DI: B-05060670520029
Reference: MPAHPV004
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Ireland
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

Papilloplex HR HPV Genotyping Kit

-

IVD generalNot specifiedOn the market

Manufacturer: GeneFirst Limited
Manufacturer SRN: GB-MF-000025181
UDI-DI: 05060670520005
Basic UDI-DI: B-05060670520005
Reference: MPAHPV001
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV Assay Calibrators Kit

-

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509566
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 302554
EMDN: W0105041002
EMDN description: SCREENING 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