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+ENTI301140760I

TBE/FSME IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140760I
Basic UDI-DI: B-+ENTI301140760I
Reference: 30114076
EMDN: W0105040612
EMDN description: FSME VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTI301140710D

Respiratory Syncytial Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140710D
Basic UDI-DI: B-+ENTI301140710D
Reference: 30114071
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

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+ENTI301140700C

Respiratory Syncytial Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140700C
Basic UDI-DI: B-+ENTI301140700C
Reference: 30114070
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

+ENTI301140690K

Respiratory Syncytial Virus IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140690K
Basic UDI-DI: B-+ENTI301140690K
Reference: 30114069
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

CHORUS WEST NILE IgM

CHORUSWNM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891324094
Basic UDI-DI: 803389132CHORUSWNM00E3
Reference: 81176
EMDN: W0105040626
EMDN description: WEST NILE VIRUS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

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CHORUS WEST NILE IgG

CHORUSWNG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891324087
Basic UDI-DI: 803389132CHORUSWNG00D5
Reference: 81174
EMDN: W0105040626
EMDN description: WEST NILE VIRUS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details

CHORUS CHIKUNGUNYA IgM

CHIKUNGUNYA

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891320218
Basic UDI-DI: 803389132CHIKUNGUNYA009F
Reference: 81134
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:15

Manufacturer products View details

Dengue IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma)

1 test/kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: 06975496250083
Basic UDI-DI: 697549625BTT012SH
Reference: BTT012-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Combo Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: 06975156250644
Basic UDI-DI: 6975156250000GZM
Reference: I008-N6025-25
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06974689730784

Mycoplasma Pneumoniae Antigen Combo Test Cassette: 1 Test/Kit

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Beijing Zhongjian Antai Diagnostic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000052880
UDI-DI: 06974689730784
Basic UDI-DI: 697468973JT73V4
Reference: JT73
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

06973642383081

1 Test ,5 Tests,25 Tests

IVD Class AIVDR 2017/746On the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642383081
Basic UDI-DI: 6973642381416S5N
Reference: Ref. DR1416S005
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

06973642381933

1 Test ,5 Tests,10 Tests,20 Tests,25 Tests,40 Tests,50 Tests,80 Tests,100 Tests

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381933
Basic UDI-DI: 6973642381401BB
Reference: N/A
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

06973642381841

1 Test ,5 Tests,10 Tests,20 Tests,25 Tests,40 Tests,50 Tests,80 Tests,100 Tests

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381841
Basic UDI-DI: 6973642381402BD
Reference: N/A
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Coxsackievirus B IgM (CLIA)

Coxsackievirus B IgM (CLIA) Controls