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358 device results listed.

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PROM Amniotic fluid Rapid Test

GHPROM

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762326
Basic UDI-DI: B-06976202762326
Reference: GHPROM-702
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

06975260987337

PCT/CRP Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06975260987337
Basic UDI-DI: B-06975260987337
Reference: 0117-03
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

06975260980451

SAA/CRP Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06975260980451
Basic UDI-DI: B-06975260980451
Reference: 0118-03
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

06975166204460

20 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166204460
Basic UDI-DI: B-06975166204460
Reference: 20 Tests/Kit
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

06975166204477

40 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166204477
Basic UDI-DI: B-06975166204477
Reference: 40 Tests/Kit
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

06975166204453

5 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166204453
Basic UDI-DI: B-06975166204453
Reference: 5 Tests/Kit
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

06975166204446

2 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166204446
Basic UDI-DI: B-06975166204446
Reference: 2 Tests/Kit
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

06975166204439

1 Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166204439
Basic UDI-DI: B-06975166204439
Reference: 1 Test/Kit
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)

50tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366051
Basic UDI-DI: B-06974849366051
Reference: HWTS-EV016A
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - 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

Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)

10 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: 06974849366044
Basic UDI-DI: B-06974849366044
Reference: HWTS-EV016B
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - 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

KEYU Giardia lamblia Antigen Detection Kit (Colloidal Gold Method)

GL-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361849
Basic UDI-DI: B-06974735361849
Reference: GL-I
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

25-Hydroxyvitamin D (25-OH-VD) Rapid Quantitative Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521002260
Basic UDI-DI: B-06974521002260
Reference: SUPF122024
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-06973914383078X5

Novel Coronavirus (2019-nCoV) Antigen Rapid Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: D-06973914383078X5
Basic UDI-DI: B-06973914383078X5
Reference: H201.03.00172.001
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:54

Manufacturer products Authorised representative products Authorised representative actors View details

06973914383108

Novel Coronavirus (2019-nCoV) Antigen Rapid Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914383108
Basic UDI-DI: B-06973914383108
Reference: H201.03.00171.001
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

06973914383092

5 tests/ kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914383092
Basic UDI-DI: B-06973914383092
Reference: H201.03.00180.001
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

06973914383085

2 tests/ kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914383085
Basic UDI-DI: B-06973914383085
Reference: H201.03.00175.001
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742541

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742541
Basic UDI-DI: B-06973316742541
Reference: R331103
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742534

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742534
Basic UDI-DI: B-06973316742534
Reference: R331102
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742527

25 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742527
Basic UDI-DI: B-06973316742527
Reference: R331101
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

06973316742510

10 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742510
Basic UDI-DI: B-06973316742510
Reference: R331100
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details