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118 device results listed.

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6 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Chaozhou Hybribio Biochemistry Ltd.
Manufacturer SRN: CN-MF-000023818
UDI-DI: 06942221701608
Basic UDI-DI: B-06942221701608
Reference: HBRT-H14
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo HPV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570541
Basic UDI-DI: B-04719878570541
Reference: PCRAD1104/ PCRAD1114
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

05745000468065

Seq-hpv-1, Seq-hpv-2

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468065
Basic UDI-DI: B-05745000468065
Reference: MFG020002
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:55

Manufacturer products View details

04897036920404

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920404
Basic UDI-DI: B-04897036920404
Reference: 92041
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920398

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920398
Basic UDI-DI: B-04897036920398
Reference: 92040
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656931
Basic UDI-DI: B-00810173656931
Reference: 2HPV18A01
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130A0108EYS33J

101A0108EY

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130A0108EYS33J
Basic UDI-DI: B-697603130A0108EYS33J
Reference: 101A0108EY
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AHPV1401DDUBT

AHPV1401D-AOG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AHPV1401DDUBT
Basic UDI-DI: B-69509960AHPV1401DDUBT
Reference: AHPV1401D-AOG48E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AHPV14013XT5

AHPV1401-AOG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AHPV14013XT5
Basic UDI-DI: B-69509960AHPV14013XT5
Reference: AHPV1401-AOG48E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

ALINITY M HR HPV

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999051249
Basic UDI-DI: 0884999AMN0041WA
Reference: 09N15-092
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

Human Papillomavirus Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: D-RA011UE
Basic UDI-DI: B-RA011UE
Reference: P122-02096
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene HPV 15 Genotyping Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP03JZ
Basic UDI-DI: B-HP03JZ
Reference: HP03021V, HP03022U
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING 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

HPV-Q Real-Time PCR Kit

G2M706721

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M706721G8
Basic UDI-DI: B-G2M706721G8
Reference: G2M706721,G2M706721R
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, Gene sequencing technology)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A021CP
Basic UDI-DI: B-A021CP
Reference: INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, Gene sequencing technology)
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING 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

ViroKey MP HPV 16, 18 PCR Test

301119, 301120, 301121

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395VKMPHPV1618TZ6
Basic UDI-DI: B-888501395VKMPHPV1618TZ6
Reference: 301119, 301120, 301121
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

High PapillomaStrip

3.146.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773146WUGQ
Basic UDI-DI: B-84295773146WUGQ
Reference: 3.146.XXX.YY.ZZZ
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

D-81649002AHPV1401M67G

AHPV1401-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1401M67G
Basic UDI-DI: B-81649002AHPV1401M67G
Reference: AHPV1401-AHG48E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING 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

D-81649002AHPV1401DUMQR

AHPV1401D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1401DUMQR
Basic UDI-DI: B-81649002AHPV1401DUMQR
Reference: AHPV1401D-AHG48E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING 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

High Risk HPV Genotyping 8-well

Step 2 Plates for High Risk HPV Genotyping 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002427
Basic UDI-DI: B-09343044002427
Reference: 23201P
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

High Risk HPV Genotyping 8-well

Step 1 tubes for High Risk HPV Genotyping 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002434
Basic UDI-DI: B-09343044002434
Reference: 23201S
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details