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AzureSeq CE qPCR Kit SARS-CoV-2 for 200 Reactions

AzureSeq-200 CE

IVD generalIVDDNo longer on the marketKitProfessional testing

Manufacturer: Omixon Biocomputing Ltd.
Manufacturer SRN: HU-MF-000003018
UDI-DI: 05999565781187
Basic UDI-DI: B-05999565781187
Reference: AzureSeq-200 CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:24

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AzureSeq 4 CE qPCR Kit for 200 Reactions

AzureSeq 4-200 CE

IVD generalIVDDNo longer on the marketKitProfessional testing

Manufacturer: Omixon Biocomputing Ltd.
Manufacturer SRN: HU-MF-000003018
UDI-DI: 05999565781231
Basic UDI-DI: B-05999565781231
Reference: AzureSeq 4-200 CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:24

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lateral flow test

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012998
Basic UDI-DI: B-05944759012998
Reference: SN 2.4
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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See Now Dengue IgG/IgM antibody test

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012431
Basic UDI-DI: B-05944759012431
Reference: SN 8.2
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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See Now Dengue NS1 antigen

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012400
Basic UDI-DI: B-05944759012400
Reference: SN 8.3
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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See Now SARSC-COV-2 + INFLUENZA A/B panel

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012387
Basic UDI-DI: B-05944759012387
Reference: SN 8.8
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

Manufacturer products View details

See Now Influenza A+B antigen test

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012271
Basic UDI-DI: B-05944759012271
Reference: SN 8.6
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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See Now Coronavirus nCoV antigen - swab

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012059
Basic UDI-DI: B-05944759012059
Reference: SN 8.7
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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Rotavirus antigen

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012004
Basic UDI-DI: B-05944759012004
Reference: SN 2.5
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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1 test/kit

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468140
Basic UDI-DI: B-05745000468140
Reference: MFG030029
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 22:56

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50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468058
Basic UDI-DI: B-05745000468058
Reference: MFG030015
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

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Seq-hpv-1, Seq-hpv-2

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468065
Basic UDI-DI: B-05745000468065
Reference: MFG020002
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:55

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4800T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468027
Basic UDI-DI: B-05745000468027
Reference: MFG030021
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:55

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50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468010
Basic UDI-DI: B-05745000468010
Reference: MFG030010
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:55

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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

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FluA qcLAMP kit

FluA qcLAMP kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testing

Manufacturer: BIOPIX DNA TECHNOLOGY P.C.
Manufacturer SRN: GR-MF-000033590
UDI-DI: 05210166000034
Basic UDI-DI: B-05210166000034
Reference: 000056
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:50

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)

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