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309 device results listed.

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SPECIMEN COLLECTION KIT

MDK-H001

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: MEDICO TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000013067
UDI-DI: 06974931658781
Basic UDI-DI: 697493165SCKISQ
Reference: MDK-H001
EMDN: W0105041099
EMDN description: HPV REAGENTS - OTHER
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:45

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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: 15420045509542
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 302929
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

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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: 15420045500112
Basic UDI-DI: 54200455DIAGAPTHPVGTVK
Reference: 303236
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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Allplex™ HPV HR Detection

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102633
Basic UDI-DI: 924010HP30370GH
Reference: HP30376L
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

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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

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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

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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

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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

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

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

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

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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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EasyPGX ready HPV

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289090903
Basic UDI-DI: 8057289090301CRT034ER
Reference: RTX034
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

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HPV Genotyping Kit (18 Types)

48 Tests/Kit

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

Manufacturer: Guangzhou KingCreate Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000032033
UDI-DI: 06974987420110
Basic UDI-DI: 697498742KS3050013R
Reference: KS305-HPV48
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Umedwings Netherlands B.V.
Last updated: 30.06.2026 12:14

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06974737220861

AmpSure® HPV Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Rendu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000018869
UDI-DI: 06974737220861
Basic UDI-DI: 697473722HPVRT2XS
Reference: HPVRT2-100CE
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Greece
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:14

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06974737220854

AmpSure® HPV 16/18 Genotype Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Rendu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000018869
UDI-DI: 06974737220854
Basic UDI-DI: 697473722HPV1618RT25E
Reference: HPV1618RT2-100CE
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Greece
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:14

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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