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Rapid Zika Virus IgG/IgM Combo Test Card

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163316073
Basic UDI-DI: B-04260163316073
Reference: 07ZIKA025AB
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:42

Manufacturer products View details

Rapid Zika Virus IgG/IgM Combo Test Card

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163316066
Basic UDI-DI: B-04260163316066
Reference: 07ZIKA001AB
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:42

Manufacturer products View details

04099466102034

Serazym® Rotavirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466102034
Basic UDI-DI: B-04099466102034
Reference: E-020
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:24

Manufacturer products View details

04099466101730

Serazym® Adenovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466101730
Basic UDI-DI: B-04099466101730
Reference: E-017
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:24

Manufacturer products View details

+ENTIPRES61340I

Mplex SARS-CoV-2+, Flu A, Flu B (C1)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRES61340I
Basic UDI-DI: B-+ENTIPRES61340I
Reference: PRES6134
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 22:53

Manufacturer products View details

+ENTIPRES61310F

Mplex SARS-CoV-2+, Flu A, Flu B (C1)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRES61310F
Basic UDI-DI: B-+ENTIPRES61310F
Reference: PRES6131
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 22:53

Manufacturer products View details

VIASURE Adenovirus plus Real Time PCR Detection Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440260097
Basic UDI-DI: 84354402_MDXRESP_ADUWH
Reference: VS-ADU101H
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:38

Manufacturer products View details

Anti-Oropouche Virus ELISA (IgM)

EI 2771 M

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016164036
Basic UDI-DI: 4049016EI2771M57
Reference: EI 2771-9601 M
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:17

Manufacturer products View details

Anti-Oropouche Virus ELISA (IgG)

EI 2771 G

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016164029
Basic UDI-DI: 4049016EI2771G4T
Reference: EI 2771-9601 G
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:17

Manufacturer products View details

10743816001522

Accusay Mono

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816001522
Basic UDI-DI: B-10743816001522
Reference: ACC-M001P
EMDN: W0105040403
EMDN description: EBV - NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

10743816001478

BioSign Flu A&B

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816001478
Basic UDI-DI: B-10743816001478
Reference: BSP-510-25
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

10743816001508

Status Flu A+B

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816001508
Basic UDI-DI: B-10743816001508
Reference: 36025
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

10743816000976

Status Mono

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816000976
Basic UDI-DI: B-10743816000976
Reference: 68364
EMDN: W0105040403
EMDN description: EBV - NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Quantification Kit (24)