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Pantest Coronavirus Ag (nasopharyngeal swab)

Pantest Coronavirus Ag (Nasopharyngeal Swab)

IVD generalIVDDOn the marketKitNear-patient testingSingle use

Manufacturer: Pantest SA
Manufacturer SRN: PT-MF-000026431
UDI-DI: 05600233273308
Basic UDI-DI: B-05600233273308
Reference: SARS-COV-2019 Ag (N)
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Portugal
Authorised representative: -
Last updated: 02.08.2026 21:51

Manufacturer products View details

DyonCovidAg

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251202290
Basic UDI-DI: B-05200251202290
Reference: DNCVAGCH
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:48

Manufacturer products View details

n-AbCovid19

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251201880
Basic UDI-DI: B-05200251201880
Reference: DNBSCVNAF
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:48

Manufacturer products View details

DyonCovid19-S (neutro)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251201828
Basic UDI-DI: B-05200251201828
Reference: DNQHCV19N
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:48

Manufacturer products View details

SieloCovidAg

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251201705
Basic UDI-DI: B-05200251201705
Reference: DNWBCVSA
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:48

Manufacturer products View details

DyonCovid19

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200890
Basic UDI-DI: B-05200251200890
Reference: DNCV19 MG
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

DyonCovid19S

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200968
Basic UDI-DI: B-05200251200968
Reference: DNWBCV19S
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

04897116730039

INDICAID COVID-19 RAPID ANTIGEN TEST

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: 04897116730039
Basic UDI-DI: B-04897116730039
Reference: 2110200
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.08.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

04560189216303

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

++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

++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

++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

++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

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

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