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EIAgen HCV Ab (v.4) Kit

++M52107106LG

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M52107106LG
Basic UDI-DI: B-++M52107106LG
Reference: 071067 / 071064 / 071068
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Poland
Authorised representative: -
Last updated: 01.08.2026 01:56

Manufacturer products View details

++B379ZKM217Q

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

++B379WNMS1AC

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

++B379STMS1AA

Scrub Typhus Detect™ IgM ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379STMS1AA
Basic UDI-DI: B-++B379STMS1AA
Reference: STMS-1
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - 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

++B379STGS19C

Scrub Typhus Detect™ IgG ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379STGS19C
Basic UDI-DI: B-++B379STGS19C
Reference: STGS-1
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - 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

++B379JEMS13W

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

++B379INS0251J

Kalazar Detect™ Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379INS0251J
Basic UDI-DI: B-++B379INS0251J
Reference: INS025
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - 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

++B379INS0201E

Kalazar Detect™ Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379INS0201E
Basic UDI-DI: B-++B379INS0201E
Reference: INS020
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - 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

++B379INS015VS

Kalazar Detect™ Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379INS015VS
Basic UDI-DI: B-++B379INS015VS
Reference: INS015
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - 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

++B379DNS11ZK

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

++B379DDMS1ZJ

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

++B379DDGS1YL

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

++B379CP050UN

Chagas Detect™ Plus Rapid Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379CP050UN
Basic UDI-DI: B-++B379CP050UN
Reference: CP050
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - 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

++B379CL025TT

CL Detect™ Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379CL025TT
Basic UDI-DI: B-++B379CL025TT
Reference: CL025
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - 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

++B379CHKMC2C

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

++B379CHKGCZP

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

Perio POC Pro Cartridge

PerioPOC Pro Cartridge

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: GENSPEED Biotech
Manufacturer SRN: AT-MF-000013008
UDI-DI: 09120131770045
Basic UDI-DI: 912013177DNACartE8
Reference: GSPC3
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

IPC

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730169
Basic UDI-DI: 912012773IPCEV
Reference: 09120127730169
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

Allplex™ GI-Virus Assay

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101674
Basic UDI-DI: 924010GI97010FP
Reference: GI10184Z
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX 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