ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)

Human papilloma virus

EMDN code W01050410

105 manufacturers, 325 models including 311 on the market, 20 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 105

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™ CFP169P5098/79 ChainFor™ CFP179P10098/79 ChainFor™ CFP179P2598/79 18 others ChainFor™ CFP179P5098/79 ChainFor™ CFP180P5098/79 ChainFor™ CFP206P2598/79 ChainFor™ CFP46P2598/79 ChainFor™ HPV 16/18 Genotyping qPCR Kit3 refs ChainFor™ HPV 16/18/45 Genotyping qPCR Kit3 refs ChainFor™ HPV ID-14 Genotyping qPCR Kit3 refs ChainFor™ HPV ID-14 Screening qPCR Kit3 refs ChainFor™ HPV ID-16 Genotyping qPCR Kit3 refs ChainFor™ LYO190WS243 refs ChainFor™ Women’s Health v1.0 Genotyping qPCR Kit3 refs LyoSens HPV 16/18 Genotyping qPCR Kit LYO4698/79 LyoSens™ LYO169WS2498/79 LyoSens™ LYO178WS9698/79 LyoSens™ LYO179WS243 refs LyoSens™ LYO206WS4898/79 RapidFor™ HPV 16/18 Test Kit RapidFor™ VMD192SC98/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Hybribio EU representative : Emergo Europe B.V. (Netherlands) and 2 others	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 13 others 20-HPV Genotype(B) ：48 Tests98/79 20-HPV Genotype(B) ：96 Tests98/79 24 Tests/ Kit98/79 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 48 Tests/Kit3 refs98/79 6 Tests/Kit4 refs98/79 60 Tests/Kit98/79 90 Tests/Kit98/79	– 98/79	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 AHPV1801-AHG48E98/79 AHPV1801-BHG48E,AHPV1801-BHG96E98/79 AHPV1801-CHG48E98/79 9 others AHPV2301-AHG48E98/79 AHPV2301D-AHG48E98/79 CHPV1401A-AHG4E98/79 CHPV1402A-AHG4E98/79 Human Papillomavirus E7 Protein Rapid Test Cassette (Swab) GCHPV-502a98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)98/79 RHPV201-AHG5E/RHPV201-AHG25E98/79 RHPV301-AHG5E/RHPV301-AHG25E98/79	– 98/79	quality@healgen.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 HPV Genotyping and Monitoring Plus Kit (24)3 refs98/79 HPV Genotyping and Monitoring Plus Kit (48)3 refs98/79 7 others HPV Genotyping and Monitoring Plus Kit (96)3 refs98/79 HPV LR Genotyping and Monitoring Kit (24)3 refs98/79 HPV LR Genotyping and Monitoring Kit (48)3 refs98/79 HPV LR Genotyping and Monitoring Kit (96)3 refs98/79 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
Sansure FDA EU representative : Lotus NL B.V. (Netherlands) and 2 others	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 15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3360E-12-P98/79 15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3360E-4898/79 7 others 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 (26 Genotypes) Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed)	C IVDR, 98/79	Website info@sansure.com.cn EUDAMED record Report an error
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&18 Real Time PCR Kit98/79 5 others HPV16/HPV18/HPV6+11 Multiplex Real Time PCR Kit98/79 HPV6&11 Real Time PCR Kit98/79 LyoHarmonyHPV Test2 refs98/79 Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit2 refs98/79 VenusHPV Test2 refs98/79	– 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 Cowingene HPV 15 E6/E7 Gene mRNA Detection Kit98/79 Cowingene HPV 15 Genotyping Detection Kit98/79 Cowingene HPV 16/18/45 Detection Kit98/79 4 others Cowingene HPV 28 Genotyping Detection Kit98/79 Cowingene HPV 6/11 Detection Kit98/79 Cowingene HPV Genotyping Detection Kit98/79 Cowingene HPV Genotyping Pro Detection Kit98/79	– 98/79	Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	AHPV1401-AOG48E98/79 AHPV1401D-AOG48E98/79 AHPV1801-AOG48E98/79 AHPV1801-BOG48E，AHPV1801-BOG96E98/79 AHPV2301-AOG48E,AHPV2301-AOG96E98/79 4 others CHPV1401A-AOG4E98/79 CHPV1402A-AOG4E98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)98/79	– 98/79	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 HPV 6/11 Tespit Kiti HPV 6/11 DETECTION KIT HPV DÜŞÜK RİSKLİ GENOTİPLEME GERÇEK ZAMANLI PCR KİTİ HPV YÜKSEK RİSK VE 6-11 GERÇEK ZAMANLI PCR KİTİ HPV HIGH RISK AND 6-11 REAL-TIME PCR KIT 4 others MINI SMEAR SET MINI SMEAR SET V2 MINI SMEAR SETİ V2 SAMPLE CONTAINER VSNS009 SMEAR SAMPLING KIT	A, C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	IHPV-502-0198/79 IHPV-502-0298/79 IHPV-502-0598/79 IHPV-502-0798/79 IHPV-502-2098/79 2 others IHPV-502-2598/79 IHPV-502-4098/79	– 98/79	office@lyher.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 15 Types of High-risk Human Papillomavirus E6/E7 Gene mRNA 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 2 others Freeze-dried Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)98/79 Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)98/79	– 98/79	marketing@hongweitest.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 Low Risk HPV Genotyping Assay98/79 Low Risk HPV Genotyping Kit (Sanity 2.0)98/79 MeltArray High Risk HPV Genotyping Assay98/79 1 other MeltArray High Risk HPV Genotyping Assay (Sanity)98/79	– 98/79	info@zsandx.com EUDAMED record Report an error
Ab Analitica	Italy	AMPLIQUALITY HPV-TYPE EXPRESS v3.02 refs98/79 REALQUALITY RQ-HPV HR Multiplex4 refs98/79 REALQUALITY RQ-HPV HR/LR Multiplex6 refs98/79 REALQUALITY RQ-HPV Screen4 refs98/79 REALQUALITY RQ-Multi HPV Detection6 refs98/79	– 98/79	customersupport@abanalitica.it 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 Anatolia Geneworks Bosphore HPV HR-LR Genotyping Kit v32 refs98/79 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
Bioeksen	Türkiye	Bio-Speedy® Human Papillomavirus 6-11-16-18-HR qPCR Kit2 refs98/79 Bio-Speedy® Human Papillomavirus Genotyping qPCR Panel5 refs98/79 Bio-Speedy® Human Papillomavirus High-Risk qPCR Panel5 refs98/79 Bio-Speedy® Human Papillomavirus Low-Medium Risk qPCR Panel5 refs98/79 Bio-Speedy® Human Papillomavirus qPCR Kit2 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
DiagCor Life Science EU representative : Medunion S.L. (Spain) and 1 other	Hong Kong SAR China	24 tests98/79 48 tests3 refs98/79 9200798/79 9200898/79 GenoQuest HPV 24 Genotyping qPCR Assay 48 tests98/79	– 98/79	QARA@diagcorlifescience.com 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 TellgenplexTM HPV27 genotyping Assay98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium)	China	Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)98/79 Human Papillomavirus Genotyping Kit for 15 Types (PCR-Reverse Dot Blot)98/79 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 Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing)98/79	– 98/79	Website 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 eSens HPV LR 6/11 genotype QL PCR kit98/79	– 98/79	Website 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
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
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Allplex™ HPV HR Detection3 refs Allplex™ HPV28 Detection2 refs Anyplex™ II HPV28 Detection2 refs98/79 Anyplex™ II HPV HR Detection3 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 16 HPV genotypes Detection kit R4898/79 EUYI High-Risk HPV Test R4898/79 EUYI HPV Genotyping Kit Plus R2598/79 EUYI HPV Genotyping Kit R2598/79	– 98/79	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 (Type 16, 18) Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 Low Risk Human Papillomavirus (Type 6, 11) Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 High Risk Human Papillomavirus (HPV) Genotyping System98/79 (no longer marketed)	C IVDR, 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
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	HPV Genotyping Real-Time PCR Kit (Fluorescent PCR) BSJ01M1， BSJ01L12 refs 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	C IVDR, 98/79	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	48 tests/kit2 refs98/79 Large package, 24 tests/kit98/79 Large package, 48 tests/kit98/79	– 98/79	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
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) 31 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
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	HPV 16/18 qPCR Kit98/79 HPV Antigen Rapid Test Cassette THPV-50298/79 HPV Antigen Rapid Test Cassette THPV-R50298/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Kangmei Tianhong Biotech (Beijing) EU representative : Lotus NL B.V. (Netherlands)	China	Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR) 12 Tests/kit98/79 Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR) 24 Tests/kit98/79 Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR) 48 Tests/kit98/79	– 98/79	Website info@kindmay.com 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 HPV16/HPV18 MPCR-ULFA Kit V033098/79 PaxView HPV20 Genotyping MPCR-ULFA Kit V032498/79	– 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 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
Rapid Labs EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	HPV 16/18 qPCR Kit-Cervical Swab2 refs98/79 HPV Antigen Rapid Test -Cervical Swab D-HPVCSD2598/79 HPV Antigen Rapid Test Device – Cervical Swab D-HPVD2098/79	– 98/79	Website info@rapidlabs.co.uk 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
Abbott FDA EU representative : Abbott GmbH (Germany)	Germany, United States	Alinity m RealTime	C IVDR	Website 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 ZENA MAX Papillomavirus (HPV) Type 6 and 11 Real Time PCR Detection Kit98/79	– 98/79	Website info@am-diagnostics.co.uk 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
Bgi	Denmark	4800T98/79 Seq-hpv-1, Seq-hpv-298/79	– 98/79	Website EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Human Papillomavirus Genotyping Real Time PCR Kit2 refs98/79 Human Papillomavirus Real Time PCR Kit98/79	– 98/79	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
Genes2Me EU representative : Obelis s.a. (Belgium)	India	HPV-Q comprehensive Real Time PCR Kit G2M80392198/79 HPV-Q Real-Time PCR Kit G2M70672198/79	– 98/79	Website EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit3 refs98/79 25 tests/kit3 refs98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0108EY98/79 101A0113EY98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Aptima HPV 16 18/45 Genotype Assay2 refs Aptima HPV Assay3 refs	C IVDR	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
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
Operon FDA	Spain	High + Low PapillomaStrip 3.148.XXX.YY.ZZZ98/79 High PapillomaStrip 3.146.XXX.YY.ZZZ98/79	– 98/79	Website infoeudamed@operon.es 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
Self-screen	Netherlands	HPV-Risk assay QHR1317298/79 QIAscreen HPV PCR test98/79	– 98/79	Website EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	AmpSure® HPV 16/18 Genotype Assay AmpSure® HPV Assay	C IVDR	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
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
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Nucleic Acid Detection Kit for High-risk Human Papillomavirus (PCR-Fluorescence Probing)98/79 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
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
Vitassay	Spain	Vitassay qPCR High-Risk HPVs98/79 Vitassay qPCR HPV98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
Vitro FDA	Spain	master diagnóstica MAD-003930MU-HS12-243 refs master diagnóstica MAD-003949M-W	C IVDR	Website regulatory@vitro.bio EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit2 refs98/79 QINGLI Strip: 25Tests/Kit2 refs98/79	– 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
Abviris	Germany	Prevo-Check98/79	– 98/79	Website info@abviris.de 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
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	HPV Test HPV-1-A98/79	– 98/79	info@actest.com.cn 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
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	Onclarity4 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
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	JWF HPV Antigen Test Kit98/79	– 98/79	EUDAMED record Report an error
Biocare Medical EU representative : Emergo Europe B.V. (Netherlands)	United States	HPV-16 (CAMVIR-1) ACI186C98/79	– 98/79	Website 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
Cepheid FDA	Sweden	Xpert®98/79	– 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
Clonit	Italy	PAPILLOMA VIRUS NESTED KIT PL.0298/79	– 98/79	Website info@clonit.it 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
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HPV IgM Rapid Test Device (serum) A111701D98/79	– 98/79	info@cybereagen.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
Euroimmun FDA	Germany	EUROArray HPV MN 25404 refs98/79	– 98/79	Website info@euroimmun.de 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
Genmark	Türkiye	geneMAP HPV HR & 6 /11 Genotyping Kit, 50T98/79	– 98/79	Website info@genmark.com.tr 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
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 Biotest Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Rightsign WHPV-C7298/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Hangzhou DIAN Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	GENEDIAN2 refs98/79	– 98/79	EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Human Papilloma Virus (HPV) Antigen Rapid Test HHPV071G98/79	– 98/79	info@jgbiotech.com 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
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HA-00298/79	– 98/79	EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Human Papillomavirus E7 Protein Rapid Test Cassette (Swab) GCHPV-502a98/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain)	China	12 reactions/kit3 refs98/79	– 98/79	support@igenesisbio.com EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	StrongStep® Screening test for Cervical Pre-cancer and Cancer 20 Tests/box98/79	– 98/79	Website sales@limingbio.com 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
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HPV IgM Rapid Test Device K410216D98/79	– 98/79	Website info@realytech.com 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
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	HPV Rapid Test kit FK00698/79	– 98/79	sales@syngenebio.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
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	MultNAT HPV Panel2 refs98/79	– 98/79	Website service@bioustar.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
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
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
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	U-Card™ 2003 refs98/79	– 98/79	Website sales@wondfo.com.cn 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) HPV （16+18）Rapid Test 20 tests/kit98/79 (no longer marketed) HPV （16+18）Rapid Test 40 tests/kit98/79 (no longer marketed) 3 others QP1：100 tests/kit2 refs98/79 (no longer marketed) QP1：25 tests/kit98/79 (no longer marketed) 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
Qiagen FDA No model still on the market	Germany	careHPV Test Kit98/79 (no longer marketed)	– 98/79	Website info@qiagen.com EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	HPV 16/18 Antigen Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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