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69 device results listed.

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Xpert®

Xpert® HPV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001179
Basic UDI-DI: B-07332940001179
Reference: GXHPV-CE-10
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

geneMAP

geneMAP HPV HR & 6 /11 Genotyping Kit, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405HPVGRT50MX
Basic UDI-DI: B-TRMF000028405HPVGRT50MX
Reference: HPVG-RT50
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:22

Manufacturer products View details

Human Papillomavirus Real Time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC80402-NW-50TM2
Basic UDI-DI: B-JC80402-NW-50TM2
Reference: JC80402-NW-50T
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene HPV (2+12) Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP02JX
Basic UDI-DI: B-HP02JX
Reference: HP02021X, HP02022X, HP02023W
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene HPV (2+16) Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP01JV
Basic UDI-DI: B-HP01JV
Reference: HP01021X, HP01022X, HP01023W
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, PCR-fluorescent probe method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A020CM
Basic UDI-DI: B-A020CM
Reference: INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, PCR-fluorescent probe method)
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A019D4
Basic UDI-DI: B-A019D4
Reference: INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHPV1801-C6P8A

AHPV1801-CHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1801-C6P8A
Basic UDI-DI: B-81649002AHPV1801-C6P8A
Reference: AHPV1801-CHG48E
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II HPV HR Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103807
Basic UDI-DI: B-08809240103807
Reference: HP10380Z
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II HPV HR Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100356
Basic UDI-DI: B-08809240100356
Reference: HP7E00L
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II HPV HR Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100349
Basic UDI-DI: B-08809240100349
Reference: HP7E00X
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

08720299843417

HPV-Risk assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Self-screen B.V.
Manufacturer SRN: NL-MF-000040204
UDI-DI: 08720299843417
Basic UDI-DI: B-08720299843417
Reference: QHR13172
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.07.2026 19:15

Manufacturer products View details

RevoDx HPV Screening plus 16/18 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215305
Basic UDI-DI: B-08684387215305
Reference: IP202601-100
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:04

Manufacturer products View details

RevoDx HPV Screening plus 16/18 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215299
Basic UDI-DI: B-08684387215299
Reference: IP202601-25
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:04

Manufacturer products View details

RevoDx HPV 6/11 Genotyping Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214414
Basic UDI-DI: B-08684387214414
Reference: IP202530-100
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 02:01

Manufacturer products View details

RevoDx HPV 6/11 Genotyping Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214407
Basic UDI-DI: B-08684387214407
Reference: IP202530-25
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 02:01

Manufacturer products View details

ChainFor HPV Screening ID-26 qPCR Kit

CFP08

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257185
Basic UDI-DI: B-08683548257185
Reference: CFP08
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:15

Manufacturer products View details

ChainFor HPV Screening ID-15 qPCR Kit

CFP07

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257178
Basic UDI-DI: B-08683548257178
Reference: CFP07
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:15

Manufacturer products 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

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