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EUDAMED Device Search

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

Last updated

03.08.2026 22:01

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781 device results listed.

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SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva

5 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: 06974849366495
Basic UDI-DI: B-06974849366495
Reference: HWTS-RT062Z
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva

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: 06974849366488
Basic UDI-DI: B-06974849366488
Reference: HWTS-RT062Y
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold 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: 06974849366310
Basic UDI-DI: B-06974849366310
Reference: HWTS-RT090B
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold 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: 06974849366303
Basic UDI-DI: B-06974849366303
Reference: HWTS-RT090A
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold 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: 06974849366297
Basic UDI-DI: B-06974849366297
Reference: HWTS-RT094B
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold 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: 06974849366280
Basic UDI-DI: B-06974849366280
Reference: HWTS-RT094A
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold 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: 06974849366242
Basic UDI-DI: B-06974849366242
Reference: HWTS-RT077A
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold 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: 06974849366235
Basic UDI-DI: B-06974849366235
Reference: HWTS-RT077B
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)

1 test/kit (Nasopharyngeal swab)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366129
Basic UDI-DI: B-06974849366129
Reference: HWTS-RT062H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)

1 test/kit (Nasal Swab)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366112
Basic UDI-DI: B-06974849366112
Reference: HWTS-RT062H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)

1 test/kit (Rachenabstrichen)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366105
Basic UDI-DI: B-06974849366105
Reference: HWTS-RT062D
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)

20 tests/kit (Speichel)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366099
Basic UDI-DI: B-06974849366099
Reference: HWTS-RT062B
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)

10 tests/kit (Speichel)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366082
Basic UDI-DI: B-06974849366082
Reference: HWTS-RT062A
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)

1 test/kit (Speichel)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366075
Basic UDI-DI: B-06974849366075
Reference: HWTS-RT062C
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

ST-025

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Shenzhen Huian Biosci Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028080
UDI-DI: 06974831192323
Basic UDI-DI: B-06974831192323
Reference: ST-025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

ST-020

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Shenzhen Huian Biosci Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028080
UDI-DI: 06974831192316
Basic UDI-DI: B-06974831192316
Reference: ST-020
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

ST-007

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Shenzhen Huian Biosci Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028080
UDI-DI: 06974831192309
Basic UDI-DI: B-06974831192309
Reference: ST-007
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

ST-005

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Shenzhen Huian Biosci Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028080
UDI-DI: 06974831192293
Basic UDI-DI: B-06974831192293
Reference: ST-005
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

ST-002

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Shenzhen Huian Biosci Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028080
UDI-DI: 06974831192286
Basic UDI-DI: B-06974831192286
Reference: ST-002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

ST-001

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Shenzhen Huian Biosci Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028080
UDI-DI: 06974831192279
Basic UDI-DI: B-06974831192279
Reference: ST-001
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details