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

Full genotyping high-risk + low-risk HPV - NA reagents

EMDN code W0105041004

34 manufacturers, 70 models including 70 on the market, 10 countries

On the market in 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
Hybribio EU representative : Emergo Europe B.V. (Netherlands) and 1 other	China	16 Tests/Kit98/79 20-HPV Genotype(A) ：16 Tests98/79 20-HPV Genotype(A) ：48 Tests98/79 20-HPV Genotype(A) ：96 Tests98/79 20-HPV Genotype(B) ：16 Tests98/79 11 others 20-HPV Genotype(B) ：48 Tests98/79 20-HPV Genotype(B) ：96 Tests98/79 30 Tests/Kit98/79 32 Tests/Kit98/79 37 HPV GenoArray Diagnostic Kit 30 Tests/Kit98/79 40-HPV Genotype(A+B) ：16 Tests98/79 40-HPV Genotype(A+B) ：48 Tests98/79 40-HPV Genotype(A+B) ：96 Tests98/79 6 Tests/Kit2 refs98/79 60 Tests/Kit98/79 90 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor™ CFP180P5098/79 ChainFor™ CFP46P2598/79 ChainFor™ HPV 16/18 Genotyping qPCR Kit3 refs ChainFor™ Women’s Health v1.0 Genotyping qPCR Kit3 refs LyoSens HPV 16/18 Genotyping qPCR Kit LYO4698/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Kingcreate EU representative : Kingsmead Service B.V. (Netherlands) and 1 other	China	HPV Genotyping Kit (18 Types) 48 Tests/Kit HPV Genotyping Kit Specification A: 1 test/tube, 24 tests/box98/79 HPV Genotyping Kit Specification B: 8 tests/strip, 24 tests/box98/79 HPV Genotyping Kit Specification C: 8 tests/strip, 24 tests/box98/79	C IVDR, 98/79	EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	HPV Genotyping and Monitoring Plus Kit (24)3 refs98/79 HPV Genotyping and Monitoring Plus Kit (48)3 refs98/79 HPV Genotyping and Monitoring Plus Kit (96)3 refs98/79	– 98/79	Website EUDAMED record Report an error
DiagCor Life Science EU representative : Medunion S.L. (Spain) and 1 other	Hong Kong SAR China	24 tests98/79 9200798/79 GenoQuest HPV 24 Genotyping qPCR Assay 48 tests98/79	– 98/79	QARA@diagcorlifescience.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	AHPV1801-BHG48E,AHPV1801-BHG96E98/79 AHPV2301-AHG48E98/79 AHPV2301D-AHG48E98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	AHPV1801-AOG48E98/79 AHPV1801-BOG48E，AHPV1801-BOG96E98/79 AHPV2301-AOG48E,AHPV2301-AOG96E98/79	– 98/79	EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene HPV 28 Genotyping Detection Kit98/79 Cowingene HPV Genotyping Pro Detection Kit98/79	– 98/79	Website EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Medunion S.L. (Spain) and 1 other	China	Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe- Based Real- Time PCR Assay)15 refs98/79 Human Papillomavirus Nucleic Acid Amplification Test Kit (FluorescentProbe-based Real-time PCR Assay）98/79	– 98/79	EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	PaxView HPV16/18/Others MPCR-ULFA Kit V030198/79 PaxView HPV20 Genotyping MPCR-ULFA Kit V032498/79	– 98/79	Website EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Allplex™ HPV28 Detection2 refs Anyplex™ II HPV28 Detection2 refs98/79	C IVDR, 98/79	Website info@seegene.com EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Medunion S.L. (Spain) and 1 other	China	EUYI HPV Genotyping Kit Plus R2598/79 EUYI HPV Genotyping Kit R2598/79	– 98/79	EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium)	China	Human Papillomavirus Genotyping Kit for 18 Types (PCR-Reverse Dot Blot)98/79 Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)2 refs98/79	– 98/79	Website EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	HPV 16/18 qPCR Assay98/79	– 98/79	info@acesolab.com EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks Bosphore HPV HR-LR Genotyping Kit v32 refs98/79	– 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Bgi	Denmark	4800T98/79	– 98/79	Website EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® Human Papillomavirus Genotyping qPCR Panel5 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Bioer FDA EU representative : MedNet EC-REP GmbH (Germany)	China	HPV Genotyping Real-Time PCR Kit (Fluorescent PCR) BSJ01M1， BSJ01L12 refs	C IVDR	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Human Papillomavirus Genotyping Real Time PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Capitalbiotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	32tests/kit98/79	– 98/79	EUDAMED record Report an error
Fujirebio FDA	Belgium	INNO-LiPA HPV Genotyping Extra II <20T,CE> 815342 refs	C IVDR	Website EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	HPV-Q comprehensive Real Time PCR Kit G2M80392198/79	– 98/79	Website EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Akso HPV Real-time PCR Kit	C IVDR	EUDAMED record Report an error
Guangzhou Biotron Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Human Papillomavirus (HPV) 31 Genotype Detection Kit (Fluorescent PCR-Melting Curve Method)2 refs98/79	– 98/79	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 Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HA-00298/79	– 98/79	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 + Low PapillomaStrip 3.148.XXX.YY.ZZZ98/79	– 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Rapid Labs EU representative : VidaQuick Biotech S.L. (Spain)	United Kingdom (ex Northern Ireland)	HPV 16/18 qPCR Kit-Cervical Swab2 refs98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Human Papillomavirus DNA (26 Genotypes) Diagnostic Kit (PCR-Fluorescence Probing)98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany)	China	TellgenplexTM HPV27 genotyping Assay98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Human Papillomavirus Nucleic Acid Kit (Fluorescent PCR)98/79	– 98/79	EUDAMED record Report an error
Vitro FDA	Spain	master diagnóstica MAD-003930MU-HS12-243 refs	C IVDR	Website regulatory@vitro.bio EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	HPV YÜKSEK RİSK VE 6-11 GERÇEK ZAMANLI PCR KİTİ HPV HIGH RISK AND 6-11 REAL-TIME PCR KIT	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error

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