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60 device results listed.

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Allplex™ HPV28 Detection

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103722
Basic UDI-DI: 924010HP10372FX
Reference: HP10372X
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AHPV23013ZTB

AHPV2301-AOG48E,AHPV2301-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AHPV23013ZTB
Basic UDI-DI: B-69509960AHPV23013ZTB
Reference: AHPV2301-AOG48E,AHPV2301-AOG96E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-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-69509960AHPV1801-BSKY7

AHPV1801-BOG48E，AHPV1801-BOG96E

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AHPV1801-BSKY7
Basic UDI-DI: B-69509960AHPV1801-BSKY7
Reference: AHPV1801-BOG48E，AHPV1801-BOG96E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-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-69509960AHPV1801-ASHXU

AHPV1801-AOG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AHPV1801-ASHXU
Basic UDI-DI: B-69509960AHPV1801-ASHXU
Reference: AHPV1801-AOG48E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-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-TD-HNVC-CED-07XE

Human Papillomavirus Nucleic Acid Kit (Fluorescent PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Henan Vacure Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023292
UDI-DI: D-TD-HNVC-CED-07XE
Basic UDI-DI: B-TD-HNVC-CED-07XE
Reference: /
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

Human Papillomavirus DNA Test Kit(Fluorescence Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: D-RA005UK
Basic UDI-DI: B-RA005UK
Reference: P122-08048; P122-08240; P122-08480
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-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

Human Papillomavirus Genotyping Real Time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC80301NW-48TW8
Basic UDI-DI: B-JC80301NW-48TW8
Reference: JC80301NW-48T
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus Genotyping Real Time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC80301NW-24TVJ
Basic UDI-DI: B-JC80301NW-24TVJ
Reference: JC80301NW
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene HPV Genotyping Pro Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP14025L8
Basic UDI-DI: B-HP14025L8
Reference: HP14025V, HP14025Y
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene HPV 28 Genotyping Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP04K3
Basic UDI-DI: B-HP04K3
Reference: HP04021V, HP04022S
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

HPV-Q comprehensive Real Time PCR Kit

G2M803921

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803921GA
Basic UDI-DI: B-G2M803921GA
Reference: G2M803921,G2M803921R
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

High + Low PapillomaStrip

3.148.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773148WYHA
Basic UDI-DI: B-84295773148WYHA
Reference: 3.148.XXX.YY.ZZZ
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

D-81649002AHPV2301M87N

AHPV2301-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV2301M87N
Basic UDI-DI: B-81649002AHPV2301M87N
Reference: AHPV2301-AHG48E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-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-81649002AHPV2301DURR7

AHPV2301D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV2301DURR7
Basic UDI-DI: B-81649002AHPV2301DURR7
Reference: AHPV2301D-AHG48E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-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-81649002AHPV1801MSAL

AHPV1801-BHG48E,AHPV1801-BHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1801MSAL
Basic UDI-DI: B-81649002AHPV1801MSAL
Reference: AHPV1801-BHG48E,AHPV1801-BHG96E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-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

Allplex™ HPV28 Detection

IVD Class CNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103739
Basic UDI-DI: 924010HP10372FX
Reference: HP10373Z
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 11.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II HPV28 Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103791
Basic UDI-DI: B-08809240103791
Reference: HP10379Z
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II HPV28 Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100332
Basic UDI-DI: B-08809240100332
Reference: HP7S00X
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

PaxView HPV20 Genotyping MPCR-ULFA Kit

V0324

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PaxGenBio Co., Ltd.
Manufacturer SRN: KR-MF-000024696
UDI-DI: 08800097500047
Basic UDI-DI: B-08800097500047
Reference: V0324
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

PaxView HPV16/18/Others MPCR-ULFA Kit

V0301

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PaxGenBio Co., Ltd.
Manufacturer SRN: KR-MF-000024696
UDI-DI: 08800097500030
Basic UDI-DI: B-08800097500030
Reference: V0301
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details