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EUDAMED Device Search

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CL AIA-PACK SARS-CoV-2-Ab CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189216303
Basic UDI-DI: B-04560189216303
Reference: 0029710
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

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

Nucleic Acid Genotyping Kit for Human Papillomavirus 29 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: 00810173656948
Basic UDI-DI: B-00810173656948
Reference: 2HPV29A01
EMDN: W0105041005
EMDN description: OTHER 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

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

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

ZIKV Detect™ 2.0 IgM Capture ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379ZKM217Q
Basic UDI-DI: B-++B379ZKM217Q
Reference: ZKM2-1
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

West Nile Detect™ IgM Capture ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379WNMS1AC
Basic UDI-DI: B-++B379WNMS1AC
Reference: WNMS-1
EMDN: W0105040626
EMDN description: WEST NILE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

JE Detect™ IgM Antibody Capture ELISA (MAC-ELISA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379JEMS13W
Basic UDI-DI: B-++B379JEMS13W
Reference: JEMS-1
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

++B379DNS1RDSXB

Dengue NS1 Detect™ Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379DNS1RDSXB
Basic UDI-DI: B-++B379DNS1RDSXB
Reference: DNS1-RD
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

DENV Detect™ NS1 ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379DNS11ZK
Basic UDI-DI: B-++B379DNS11ZK
Reference: DNS1-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

DENV Detect™ IgM Capture ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379DDMS1ZJ
Basic UDI-DI: B-++B379DDMS1ZJ
Reference: DDMS-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

DENV Detect™ IgG ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379DDGS1YL
Basic UDI-DI: B-++B379DDGS1YL
Reference: DDGS-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

CHIKjj Detect™ IgM ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379CHKMC2C
Basic UDI-DI: B-++B379CHKMC2C
Reference: CHKM-C
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

CHIKjj Detect™ IgG ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379CHKGCZP
Basic UDI-DI: B-++B379CHKGCZP
Reference: CHKG-C
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Dengue NS1 Ag

ichroma™ Dengue NS1 Ag

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042212
Basic UDI-DI: 880613300028BR
Reference: CFPC-62
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Dengue IgG/IgM

ichroma™ Dengue IgG/IgM

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042137
Basic UDI-DI: 880613300027BP
Reference: CFPC-60
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Hungary
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Dengue IgG/IgM

AFIAS Dengue IgG/IgM

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042090
Basic UDI-DI: 880613300548CQ
Reference: SMFP-41
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS NORO

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133041796
Basic UDI-DI: 880613300530C5
Reference: SMFP-26
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

VZV qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115806796
Basic UDI-DI: 868511580PCR138GU
Reference: LYO138WS96
EMDN: W0105040399
EMDN description: HSV REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:29

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NiPV qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115804563
Basic UDI-DI: 868511580PCR127GP
Reference: LYO127WS24
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:29

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HPV ID-14 Screening qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115804365
Basic UDI-DI: 868521452PCR173GF
Reference: CFP178P25
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:29

Manufacturer products View details

HSV-1/HSV-2 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035832
Basic UDI-DI: 868511580PCR139GW
Reference: CFP139P25
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:29

Manufacturer products View details