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EIAgen Detect HIV Combo Kit

++M52108131C

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M52108131CB3
Basic UDI-DI: B-++M52108131CB3
Reference: 081311C / 081312C / 081315C
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Hungary
Authorised representative: -
Last updated: 01.08.2026 01:56

Manufacturer products View details

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

++B261CANVD510KZ

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANVD510KZ
Basic UDI-DI: B-++B261CANVD510KZ
Reference: CAN-VD-510
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANTSH408068

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANTSH408068
Basic UDI-DI: B-++B261CANTSH408068
Reference: CAN-TSH-4080
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details