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303 device results listed.

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28 Types of Human Papillomavirus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071480ABRZ
Basic UDI-DI: B-0000128071480ABRZ
Reference: HWTS-CC006
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: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

17 Types of Human Papillomavirus (16/18/6/11/44 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071470A4QY
Basic UDI-DI: B-0000128071470A4QY
Reference: HWTS-CC015
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: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

15 Types of High-risk Human Papillomavirus E6/E7 Gene mRNA Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071430A0PU
Basic UDI-DI: B-0000128071430A0PU
Reference: HWTS-CC005
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

14 Types of High-risk Human Papillomavirus (16/18 Typing) Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071410A2PJ
Basic UDI-DI: B-0000128071410A2PJ
Reference: HWTS-CC007
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: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071400A3PD
Basic UDI-DI: B-0000128071400A3PD
Reference: HWTS-CC007
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: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

HPV ID-14 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257192
Basic UDI-DI: 868499827PCR123YL
Reference: CFP123P100
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:32

Manufacturer products View details

Laborant HPV Genotyping Kit (96)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000033765
UDI-DI: 08682792797393
Basic UDI-DI: 8682792797393J9
Reference: LMHG-01-96
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:07

Manufacturer products View details

Laborant HPV Genotyping Kit (48)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000033765
UDI-DI: 08682792797386
Basic UDI-DI: 8682792797386JC
Reference: LMHG-01-48
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:07

Manufacturer products View details

Laborant HPV Genotyping Kit (24)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000033765
UDI-DI: 08682792797379
Basic UDI-DI: 8682792797379JF
Reference: LMHG-01-24
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:07

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998279444
Basic UDI-DI: 868499827PCR123YL
Reference: LYO123WS24
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998279482
Basic UDI-DI: 868499827PCR123YL
Reference: LYO123WS48
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:35

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998279512
Basic UDI-DI: 868499827PCR123YL
Reference: LYO123WS96
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:35

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031209
Basic UDI-DI: 868499827PCR123YL
Reference: CFP123P25
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:35

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032817
Basic UDI-DI: 868499827PCR123YL
Reference: CFP123P50
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:35

Manufacturer products View details

SPECIMEN COLLECTION KIT

MDK-H001

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: MEDICO TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000013067
UDI-DI: 06974931658781
Basic UDI-DI: 697493165SCKISQ
Reference: MDK-H001
EMDN: W0105041099
EMDN description: HPV REAGENTS - OTHER
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:45

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509542
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 302929
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV 16 18/45 Genotype Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500112
Basic UDI-DI: 54200455DIAGAPTHPVGTVK
Reference: 303236
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV HR Detection

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102633
Basic UDI-DI: 924010HP30370GH
Reference: HP30376L
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV HR Detection

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102626
Basic UDI-DI: 924010HP30370GH
Reference: HP30371Z
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV HR Detection

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102619
Basic UDI-DI: 924010HP30370GH
Reference: HP30370X
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details