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Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）

K590516D

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050051
Basic UDI-DI: B-06971792050051
Reference: K590516D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)

K601416D

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050037
Basic UDI-DI: B-06971792050037
Reference: K601416D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ SARS-CoV-2 IgM

100 TESTS

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439999
Basic UDI-DI: B-06971390439999
Reference: 010220101
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ SARS-CoV-2 IgG

100 TESTS

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439975
Basic UDI-DI: B-06971390439975
Reference: 010219101
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)

SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229657
Basic UDI-DI: B-06971042229657
Reference: CG-0003-20
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

SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)

SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229640
Basic UDI-DI: B-06971042229640
Reference: CG-0003-01
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 (ELISA),

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),

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

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)

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

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

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

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

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

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

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