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SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA),

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229626
Basic UDI-DI: B-06971042229626
Reference: EL-0001-96
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralization Antibody Detection Kit (Colloidal Gold),

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229633
Basic UDI-DI: B-06971042229633
Reference: CG-0004-20
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Liferiver SARS-CoV-2 484A Mutation Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229589
Basic UDI-DI: B-06971042229589
Reference: RR-0506-02-25
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit (Colloidal Gold)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229541
Basic UDI-DI: B-06971042229541
Reference: CG-0002-20
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (SARS-CoV-2) Antigen and Antibody Assay kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229534
Basic UDI-DI: B-06971042229534
Reference: CG-0001-20
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hantavirus Renal Syndrome Type II Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229381
Basic UDI-DI: B-06971042229381
Reference: QR-0236-02
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

Noroviruses Antigen Test Kit (Colloidal Gold)

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062780786
Basic UDI-DI: B-06952062780786
Reference: NV1FE-25
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126199
Basic UDI-DI: B-06936983126199
Reference: IRAC-625
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

"Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete "

Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126182
Basic UDI-DI: B-06936983126182
Reference: IRAC-625
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Dengue NS1 Antigen Test Card

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163316035
Basic UDI-DI: B-04260163316035
Reference: 07DEN025AG
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:51

Manufacturer products View details

PreventID® Influenza A+B

IVD generalIVDDOn the marketKitNear-patient testingSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013377
Basic UDI-DI: B-04050598013377
Reference: KST50112GP
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

TBE virus (FSME) IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004665
Basic UDI-DI: B-04049325004665
Reference: RE57401
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:10

Manufacturer products View details

TROD'DENGUE

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742660
Basic UDI-DI: B-03770011742660
Reference: TR-DEN-002
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

Manufacturer products View details

ALL IN DUO

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742318
Basic UDI-DI: B-03770011742318
Reference: TR-COG-002
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

Manufacturer products View details

COV-GRIP

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742073
Basic UDI-DI: B-03770011742073
Reference: TR-COG-001
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

Manufacturer products View details

COVID-VIRO

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742042
Basic UDI-DI: B-03770011742042
Reference: TR-COV-006
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

Manufacturer products View details

Toda Autotest Nasal Covid-19

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309512006
Basic UDI-DI: B-03760309512006
Reference: 2276-AT-NS-10
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:59

Manufacturer products View details

Toda Fluronadiag 1

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309511818
Basic UDI-DI: B-03760309511818
Reference: 24CO2-1
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:59

Manufacturer products View details

Toda Dengdiag combo 1

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309510675
Basic UDI-DI: B-03760309510675
Reference: 22MT7-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details

Toda Dengdiag combo 10

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TODA PHARMA
Manufacturer SRN: FR-MF-000007152
UDI-DI: 03760309510668
Basic UDI-DI: B-03760309510668
Reference: 22MT7-10
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 21:58

Manufacturer products View details