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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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258 device results listed.

Page 11 / 13

80 tests

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381100
Basic UDI-DI: B-06973642381100
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

50 tests

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381094
Basic UDI-DI: B-06973642381094
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

40 tests

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381087
Basic UDI-DI: B-06973642381087
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

25 tests

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381070
Basic UDI-DI: B-06973642381070
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

20 tests

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381063
Basic UDI-DI: B-06973642381063
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

5 tests

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381049
Basic UDI-DI: B-06973642381049
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

1 test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381032
Basic UDI-DI: B-06973642381032
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

10 tests

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642381056
Basic UDI-DI: B-06973642381056
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

5 tests

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642380028
Basic UDI-DI: B-06973642380028
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

1 test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000034480
UDI-DI: 06973642380011
Basic UDI-DI: B-06973642380011
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: 06.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Reagents (include Calibrator and Control): 100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719600991
Basic UDI-DI: B-06972719600991
Reference: 215740003
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:33

Manufacturer products Authorised representative products Authorised representative actors View details

Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold)

k771616D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050884
Basic UDI-DI: B-06971792050884
Reference: K771616D
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Human Monkeypox Virus (MPV) IgG/IgM Antibody Rapid Test Device(Colloidal Gold)

K760216D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050853
Basic UDI-DI: B-06971792050853
Reference: K760216D
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:52

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

SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method)

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807183262QQ
Basic UDI-DI: B-000012807183262QQ
Reference: HWTS-RT170B
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method)

1 test/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807183107QB
Basic UDI-DI: B-000012807183107QB
Reference: HWTS-RT170A
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Combo Rapid Test

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

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

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