Infectious diseasesOther virology tests (infect. immunology/NAT)Human papilloma virus

Screening high-risk HPV - NA reagents

EMDN code W0105041002

34 manufacturers, 63 models including 62 on the market, 11 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 34

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Vitrosens	Türkiye	ChainFor HPV Screening ID-15 qPCR Kit CFP0798/79 ChainFor HPV Screening ID-26 qPCR Kit CFP0898/79 ChainFor™ CFP179P10098/79 ChainFor™ CFP179P2598/79 ChainFor™ CFP179P5098/79 3 others ChainFor™ HPV ID-14 Screening qPCR Kit3 refs LyoSens™ LYO178WS9698/79 LyoSens™ LYO179WS243 refs	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx HPV 14 Genotyping Kit2 refs98/79 RevoDx HPV 26 Screening Kit2 refs98/79 RevoDx HPV 6/11 Genotyping Kit2 refs98/79 RevoDx HPV Screening plus 16/18 Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Sansure FDA EU representative : OSEN GmbH (Germany) and 1 other	China	15 High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing)98/79 15 High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed)	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks Bosphore HPV Screening Kit v13 refs98/79 Anatolia Geneworks Bosphore HPV Screening Kit v23 refs98/79 Anatolia Geneworks Bosphore hrHPV Screening Kit v13 refs98/79	– 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	HPV Screening and Monitoring Kit (24)3 refs98/79 HPV Screening and Monitoring Kit (48)3 refs98/79 HPV Screening and Monitoring Kit (96)3 refs98/79	– 98/79	Website EUDAMED record Report an error
GeneFirst EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Papilloplex HR HPV Genotyping Kit98/79 Papilloplex® HR-HPV DNA Kit98/79 Papilloplex® HR-HPV mRNA Kit98/79	– 98/79	Website EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene HPV (2+12) Detection Kit98/79 Cowingene HPV (2+16) Detection Kit98/79	– 98/79	Website EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	AHPV1801-CHG48E98/79 CHPV1401A-AHG4E98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, PCR-fluorescent probe method)98/79 INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)98/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
Rastin EU representative : Source of Commerce GmbH (Germany)	Iran	Rastin HI25 Rastin HI50G	C IVDR	Website EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Allplex™ HPV HR Detection3 refs Anyplex™ II HPV HR Detection3 refs98/79	C IVDR, 98/79	Website info@seegene.com EUDAMED record Report an error
Self-screen	Netherlands	HPV-Risk assay QHR1317298/79 QIAscreen HPV PCR test98/79	– 98/79	Website EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	HPV16&18 Real Time PCR Kit98/79 Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Human Papillomavirus (HPV) Nucleic Acid Typing Detection Kit 1.198/79 Human Papillomavirus (HPV) Nucleic Acid Typing Detection Kit 2.198/79	– 98/79	EUDAMED record Report an error
Triplex International Biosciences (China) EU representative : Lotus NL B.V. (Netherlands)	China	13 Types of High-Risk Human Papillomavirus Nucleic Acid Detection Kit (PCR-Fluorescent Probe）98/79 Human Papillomavirus 16 & 18 Nucleic Acid Detection Kit (PCR-Fluorescent Probe)98/79	– 98/79	Website info@tibchina.com EUDAMED record Report an error
Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Logilet HPV Panel VD401198/79 Logilet Hr-HPV Panel DHPV01M98/79	– 98/79	EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Human Papillomavirus（HPV）DNA Diagnostic Kit 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY RQ-HPV Screen4 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	ZENA MAX Papillomavirus (HPV) Type 16 and 18 Real Time PCR Detection Kit98/79	– 98/79	Website info@am-diagnostics.co.uk EUDAMED record Report an error
Arghavan Teb Kavian EU representative : Medisol Technologies S.L. (Spain)	Iran	ATK HPV	C IVDR	Website info@atkdiagnostic.com EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® Human Papillomavirus qPCR Kit2 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Human Papillomavirus Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Cepheid FDA	Sweden	Xpert®98/79	– 98/79	Website EUDAMED record Report an error
DiagCor Life Science EU representative : Medunion S.L. (Spain)	Hong Kong SAR China	48 tests98/79	– 98/79	QARA@diagcorlifescience.com EUDAMED record Report an error
Euroimmun FDA	Germany	EUROArray HPV MN 25404 refs98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Genmark	Türkiye	geneMAP HPV HR & 6 /11 Genotyping Kit, 50T98/79	– 98/79	Website info@genmark.com.tr EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Aptima HPV Assay3 refs	C IVDR	EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain)	China	12 reactions/kit98/79	– 98/79	support@igenesisbio.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	15 Types of High-risk Human Papillomavirus E6/E7 Gene mRNA Detection Kit (Fluorescence PCR)98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	CHPV1401A-AOG4E98/79	– 98/79	EUDAMED record Report an error
Pharmaline	Türkiye	UniPatogen CerviPan HPV qPCR Screening Kit3 refs	C IVDR	info@pharmaline.com.tr EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STANDARD™ M10 Hr-HPV M10-HPV-02	C IVDR	Website EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) HPV002-4898/79	– 98/79	sales@singuway.com EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands)	China	VIUICK Diagnostic Kit for Human Papilloma Virus 14 High-Risk Genotyping DNA (Real-Time PCR Method)98/79	– 98/79	EUDAMED record Report an error

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