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

Partial genotyping high-risk HPV - NA reagents

EMDN code W0105041003

55 manufacturers, 118 models including 109 on the market, 13 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 55

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
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	HarmoniaHPV Test3 refs98/79 High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-Fluorescence)3 refs98/79 High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit2 refs98/79 High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit（PCR-Fluorescence）2 refs98/79 HPV16/HPV18/HPV6+11 Multiplex Real Time PCR Kit98/79 3 others LyoHarmonyHPV Test2 refs98/79 Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit98/79 VenusHPV Test2 refs98/79	– 98/79	Website EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor™ CFP169P5098/79 ChainFor™ CFP206P2598/79 ChainFor™ HPV 16/18/45 Genotyping qPCR Kit3 refs ChainFor™ HPV ID-14 Genotyping qPCR Kit3 refs ChainFor™ HPV ID-16 Genotyping qPCR Kit3 refs 2 others LyoSens™ LYO169WS2498/79 LyoSens™ LYO206WS4898/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	14 Types of High-risk Human Papillomavirus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 17 Types of Human Papillomavirus (16/18/6/11/44 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 18 Types of High-risk Human Papilloma Virus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Freeze-dried 14 Types of Human Papillomavirus Nucleic Acid Typing Detection Kit (Fluorescence PCR)98/79 Freeze-dried Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)98/79 1 other Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human papillomavirus (Type 16 and 18) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs	C IVDR, 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	United States	AHPV1401-AHG48E98/79 AHPV1401D-AHG48E98/79 CHPV1402A-AHG4E98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	AHPV1401-AOG48E98/79 AHPV1401D-AOG48E98/79 CHPV1402A-AOG4E98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)98/79	– 98/79	EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	HPV 2+1298/79 HPV 5+998/79 HPV15 Genotyping Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 Human Papillomavirus Nucleic Acid Detection and 16/18 Typing Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	High Risk HPV Genotyping Assay (MMCA)98/79 High Risk HPV Genotyping Kit (Sanity 2.0)98/79 MeltArray High Risk HPV Genotyping Assay98/79 MeltArray High Risk HPV Genotyping Assay (Sanity)98/79	– 98/79	info@zsandx.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	HPV Genotyping and Monitoring Kit (24)3 refs98/79 HPV Genotyping and Monitoring Kit (48)3 refs98/79 HPV Genotyping and Monitoring Kit (96)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	Laborant HPV Genotyping Kit (24) Laborant HPV Genotyping Kit (48) Laborant HPV Genotyping Kit (96)	A IVDR	Website info@antmedical.com EUDAMED record Report an error
Ecolidx	Czechia	eSens HPV HR 14 genotype QT PCR kit98/79 eSens HPV HR 14 screen/16,18,45 genotype QT PCR kit98/79 eSens HPV HR 16/18 genotype QT PCR kit98/79	– 98/79	Website EUDAMED record Report an error
Targetingone EU representative : SUNGO Europe B.V. (Netherlands)	China	High-risk HPV genotyping real-time PCR detection kit PV02-1Y2498/79 HPV nucleic acid real-time PCR detection kit PV01-1Y3298/79 HPV nucleic acid real-time PCR detection kit PV01-2Y3298/79	– 98/79	EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY RQ-HPV HR Multiplex4 refs98/79 REALQUALITY RQ-Multi HPV Detection6 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta)	Australia	Step 1 tubes for High Risk HPV Genotyping 8-well98/79 Step 2 Plates for High Risk HPV Genotyping 8-well98/79	– 98/79	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® Human Papillomavirus 6-11-16-18-HR qPCR Kit2 refs98/79 Bio-Speedy® Human Papillomavirus High-Risk qPCR Panel5 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HPV Nucleic Acid Detection and 16/18 Genotyping Kit (Fluorescent PCR) BSJ50L198/79 HPV Nucleic Acid Detection and 16/18 Genotyping Kit (Fluorescent PCR) BSJ50M198/79	– 98/79	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
DiagCor Life Science EU representative : Medunion S.L. (Spain) and 1 other	Hong Kong SAR China	48 tests2 refs98/79 9200898/79	– 98/79	QARA@diagcorlifescience.com EUDAMED record Report an error
Geneproof	Czechia	GeneProof Human Papillomavirus (HPV) Screening PCR Kit2 refs98/79 TaqPath™ Menu98/79	– 98/79	Website support@geneproof.com EUDAMED record Report an error
Guangzhou Biotron Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Human Papillomavirus (HPV) 15 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)2 refs98/79 Human Papillomavirus (HPV) E6/E7 mRNA Genotyping Detection Kit (Fluorescent PCR Melting Curve Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Hybribio EU representative : Emergo Europe B.V. (Netherlands)	China	48 Tests/Kit98/79 6 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands)	China	HPV Genotyping Kit (PCR capillary analysis) (F650)98/79 HPV Genotyping Kit (PCR-Capillary Electrophoresis Fragment Analysis) (F488)98/79	– 98/79	EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Medunion S.L. (Spain) and 1 other	China	EUYI 16 HPV genotypes Detection kit R4898/79 EUYI High-Risk HPV Test R4898/79	– 98/79	EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing) 48 Tests/kit98/79 HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit(PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR High-Risk HPVs98/79 Vitassay qPCR HPV98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	HPV (16-18) HIGH RISK DETECTION KIT HPV (16-18-31) HIGH RISK DETECTION KIT	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium)	China	Human Papillomavirus Genotyping Kit for 15 Types (PCR-Reverse Dot Blot)98/79 Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing)98/79	– 98/79	Website EUDAMED record Report an error
Daltonbio EU representative : MedPath GmbH (Germany) and 1 other	China	DH3 High-Risk HPV DNA Test3 refs High Risk Human Papillomavirus (HPV) Genotyping System98/79 (no longer marketed)	C IVDR, 98/79	Website EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks Bosphore HPV Genotyping High Risk Kit v33 refs98/79	– 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	Onclarity2 refs	C IVDR	Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	PCR-based HPV Test and 1618 Genotyping Test Kit (Fluorometric PCR)98/79	– 98/79	EUDAMED record Report an error
Bgi	Denmark	Seq-hpv-1, Seq-hpv-298/79	– 98/79	Website EUDAMED record Report an error
Chengdu One-Chip Biotechnology EU representative : Share info GmbH (Germany)	China	eTrust® 1 test/kit98/79	– 98/79	EUDAMED record Report an error
Clongene FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HPV 18 High-Risk with 16/18 Genotyping PCR Test Kit IHPVk0Ns98/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene HPV 15 Genotyping Detection Kit98/79	– 98/79	Website EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	VitaSIRO solo HPV Assay98/79	– 98/79	service@credodxbiomed.com EUDAMED record Report an error
Diatech Pharmacogenetics	Italy	EasyPGX ready HPV	C IVDR	Website info@diatechpharmacogenetics.com EUDAMED record Report an error
Edna	Türkiye	CarciScan HPV PCR Assay for Cervical Cancer Screening Genotyping for HPV16, HPV18 and HPV 45 (CS3), 100 tests98/79	– 98/79	Website EUDAMED record Report an error
ElitechGroup FDA	Italy	HPV PLUS - ELITe Positive Control2 refs	C IVDR	Website EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	HPV-Q Real-Time PCR Kit G2M70672198/79	– 98/79	Website EUDAMED record Report an error
Gold Probe Diagnostic Biotechnology Mf EU representative : Lotus NL B.V. (Netherlands)	China	Human Papillomavirus Detection Kit (Multiplex Real-time PCR)98/79	– 98/79	EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0108EY98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Hangzhou DIAN Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	GENEDIAN98/79	– 98/79	EUDAMED record Report an error
Hangzhou New Horizon Health Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	48 tests/ kit98/79	– 98/79	Website compliance@nhbio.com.cn EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Aptima HPV 16 18/45 Genotype Assay2 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
Operon FDA	Spain	High PapillomaStrip 3.146.XXX.YY.ZZZ98/79	– 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	PaxView HPV16/HPV18 MPCR-ULFA Kit V033098/79	– 98/79	Website 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, Gene sequencing technology)98/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	AmpSure® HPV 16/18 Genotype Assay	C IVDR	EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Nucleic Acid Detection Kit for High-risk Human Papillomavirus (PCR-Fluorescence Probing)98/79	– 98/79	sales@singuway.com EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) HPV002FD98/79	– 98/79	sales@ukinbio.com EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	ViroKey MP HPV 16, 18 PCR Test 301119, 301120, 30112198/79	– 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error
Vitro FDA	Spain	master diagnóstica MAD-003949M-W	C IVDR	Website regulatory@vitro.bio EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	AP1：24 tests/kit98/79 (no longer marketed) AP1：48 tests/kit98/79 (no longer marketed) AP1：96 tests/kit98/79 (no longer marketed) QP1：100 tests/kit2 refs98/79 (no longer marketed) QP1：25 tests/kit98/79 (no longer marketed) 1 other QP1：50 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	100 Tests/kit98/79 (no longer marketed) 50 Tests/kit98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error

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