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+ENTI301140420B

Hantavirus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140420B
Basic UDI-DI: B-+ENTI301140420B
Reference: 30114042
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301134410D

Zika Virus IgM μ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134410D
Basic UDI-DI: B-+ENTI301134410D
Reference: 30113441
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

CerTest CLIA Rotavirus Ag

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440259046
Basic UDI-DI: 84354402CLIGASTROB_RTV46
Reference: CL-RTV001
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

OnSite® Dengue Ag Rapid Test

R0063C

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114460023
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-WHATOCOVFLUF9

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-WHATOCOVFLUF9
Basic UDI-DI: B-WHATOCOVFLUF9
Reference: WH-AT-OCOVFLU
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-WHATOCOVAgAbhP9

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-WHATOCOVAgAbhP9
Basic UDI-DI: B-WHATOCOVAgAbhP9
Reference: WH-AT-OCOVAgAbh
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-WHATOCOVAgAbYA

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-WHATOCOVAgAbYA
Basic UDI-DI: B-WHATOCOVAgAbYA
Reference: WH-AT-OCOVAgAb
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

WH Accu Test®

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-WHATOCOVAg08UJ
Basic UDI-DI: B-WHATOCOVAg08UJ
Reference: WHATOCOV080202
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

First Sign®

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-WHATOCOVAg01U4
Basic UDI-DI: B-WHATOCOVAg01U4
Reference: WH-AT-OCOV010202
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Ag Rapid Test

WELL22-16AG

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-WELL22-16AG2R
Basic UDI-DI: B-WELL22-16AG2R
Reference: WELL22-16AG
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

IgM/IgG Rapid Test

WELL22-16AB

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-WELL22-16AB2F
Basic UDI-DI: B-WELL22-16AB2F
Reference: WELL22-16AB
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Flu A/FIu B Ag

VLD01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VLD0136
Basic UDI-DI: B-VLD0136
Reference: VLD01-03-13
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:24

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgM/IgG / SARS-CoV-2 IgM/IgG

VID35

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID3532
Basic UDI-DI: B-VID3532
Reference: VID35
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Rotavirus/Adenovirus Test Kit (FIA)

VID112

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID112EL
Basic UDI-DI: B-VID112EL
Reference: VID112-01-011
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody

VCD18

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VCD18ZM
Basic UDI-DI: B-VCD18ZM
Reference: VCD18
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-554E

Dengue IgG & IgM Antibody Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-554E
Basic UDI-DI: B-TD-HNKX-CED-554E
Reference: /
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-5044

Dengue Virus Antigen Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-5044
Basic UDI-DI: B-TD-HNKX-CED-5044
Reference: /
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-303W

Multiple (6 Items) Respiratory Virus Antibody Kit (Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-303W
Basic UDI-DI: B-TD-HNKX-CED-303W
Reference: /
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-294D

Multiple (4 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-294D
Basic UDI-DI: B-TD-HNKX-CED-294D
Reference: /
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-284B

Multiple (5 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-284B
Basic UDI-DI: B-TD-HNKX-CED-284B
Reference: /
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details