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20 device results listed.

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D-697603130A0113EYRH3D

101A0113EY

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130A0113EYRH3D
Basic UDI-DI: B-697603130A0113EYRH3D
Reference: 101A0113EY
EMDN: W0105041005
EMDN description: OTHER 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

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: 00884999047914
Basic UDI-DI: 0884999AMN0915XN
Reference: 09N15-080
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene HPV Genotyping Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP12K2
Basic UDI-DI: B-HP12K2
Reference: HP12021X, HP13021V
EMDN: W0105041005
EMDN description: OTHER 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 6/11 Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP11JY
Basic UDI-DI: B-HP11JY
Reference: HP11021X, HP11023W
EMDN: W0105041005
EMDN description: OTHER 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 16/18/45 Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP10JW
Basic UDI-DI: B-HP10JW
Reference: HP10023W
EMDN: W0105041005
EMDN description: OTHER 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 15 E6/E7 Gene mRNA Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HP05K5
Basic UDI-DI: B-HP05K5
Reference: HP05021X, HP05022X
EMDN: W0105041005
EMDN description: OTHER 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

D-81649002RHPV301RBBS

RHPV301-AHG5E/RHPV301-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002RHPV301RBBS
Basic UDI-DI: B-81649002RHPV301RBBS
Reference: RHPV301-AHG5E/RHPV301-AHG25E
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002RHPV201R6AR

RHPV201-AHG5E/RHPV201-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002RHPV201R6AR
Basic UDI-DI: B-81649002RHPV201R6AR
Reference: RHPV201-AHG5E/RHPV201-AHG25E
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHPV1801AVBRB

AHPV1801-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1801AVBRB
Basic UDI-DI: B-81649002AHPV1801AVBRB
Reference: AHPV1801-AHG48E
EMDN: W0105041005
EMDN description: OTHER 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

15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

S3360E-12-P

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 16955792730639
Basic UDI-DI: B-16955792730639
Reference: S3360E-12-P
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:12

Manufacturer products Authorised representative products Authorised representative actors View details

15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

S3360E-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 16955792730622
Basic UDI-DI: B-16955792730622
Reference: S3360E-48
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:12

Manufacturer products Authorised representative products Authorised representative actors View details

HPV6&11 Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229428
Basic UDI-DI: B-06971042229428
Reference: SD-0018-02
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

06974737220861

AmpSure® HPV Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Rendu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000018869
UDI-DI: 06974737220861
Basic UDI-DI: 697473722HPVRT2XS
Reference: HPVRT2-100CE
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Greece
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
Manufacturer SRN: CN-MF-000014412
UDI-DI: 06970877681333
Basic UDI-DI: B-06970877681333
Reference: 1203
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)

24 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
Manufacturer SRN: CN-MF-000014412
UDI-DI: 06970877681326
Basic UDI-DI: B-06970877681326
Reference: 1202
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)

12 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
Manufacturer SRN: CN-MF-000014412
UDI-DI: 06970877681319
Basic UDI-DI: B-06970877681319
Reference: 1201
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

S3360E-12-P

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730632
Basic UDI-DI: B-06955792730632
Reference: S3360E-12-P
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

S3360E-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730625
Basic UDI-DI: B-06955792730625
Reference: S3360E-48
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004480
Basic UDI-DI: B-06950996004480
Reference: 2HPV29A11
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999047921
Basic UDI-DI: 0884999AMN0915XN
Reference: 09N15-090
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: -
Authorised representative: Abbott GmbH
Last updated: 19.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details