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413 device results listed.

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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

Cowingene HPV (2+12) Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP02JX
Basic UDI-DI: B-HP02JX
Reference: HP02021X, HP02022X, HP02023W
EMDN: W0105041002
EMDN description: SCREENING 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

Cowingene HPV (2+16) Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP01JV
Basic UDI-DI: B-HP01JV
Reference: HP01021X, HP01022X, HP01023W
EMDN: W0105041002
EMDN description: SCREENING 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

Human Papillomavirus E7 Protein Rapid Test Cassette (Swab)

GCHPV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHPV-502aHG9Q
Basic UDI-DI: B-GCHPV-502aHG9Q
Reference: GCHPV-502a
EMDN: W0105041001
EMDN description: HPV ANTIGEN / ANTIBODIES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus E7 Protein Rapid Test Cassette (Swab)

GCHPV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHPV-502a7S
Basic UDI-DI: B-GCHPV-502a7S
Reference: GCHPV-502a
EMDN: W0105041099
EMDN description: HPV REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

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

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

HPV Rapid Test kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349FK006FX
Basic UDI-DI: B-CNMF000054349FK006FX
Reference: FK006
EMDN: W0105041001
EMDN description: HPV ANTIGEN / ANTIBODIES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:09

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

INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, PCR-fluorescent probe method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A020CM
Basic UDI-DI: B-A020CM
Reference: INDICAID™ Human Papillomavirus Nucleic Acid Test (Urine, PCR-fluorescent probe method)
EMDN: W0105041002
EMDN description: SCREENING 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

INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A019D4
Basic UDI-DI: B-A019D4
Reference: INDICAID™ Human Papillomavirus Nucleic Acid Test (vaginal or cervical swab, PCR-fluorescent probe method)
EMDN: W0105041002
EMDN description: SCREENING 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 + 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

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-81649002RHPV301RBBS

RHPV301-AHG5E/RHPV301-AHG25E