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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

Kit de Prueba de Metalopeptidasa Matricial 9 (MMP-9 POC)

S05B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Seinda Biomedical Corporation
Manufacturer SRN: CN-MF-000047055
UDI-DI: 06972976463278
Basic UDI-DI: B-06972976463278
Reference: S05B-020, S05B-050
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 16:18

Manufacturer products Authorised representative products Authorised representative actors View details

Kit de Prueba de Linfotoxina-α (LTA POC)

S02B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Seinda Biomedical Corporation
Manufacturer SRN: CN-MF-000047055
UDI-DI: 06972976463254
Basic UDI-DI: B-06972976463254
Reference: S02B-020, S02B-050
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 16:18

Manufacturer products Authorised representative products Authorised representative actors View details

MMP9-POC

S05B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Seinda Biomedical Corporation
Manufacturer SRN: CN-MF-000047055
UDI-DI: 06972976463193
Basic UDI-DI: B-06972976463193
Reference: S05B-020, S05B-050
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 16:18

Manufacturer products Authorised representative products Authorised representative actors View details

LTA-POC

S02B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Seinda Biomedical Corporation
Manufacturer SRN: CN-MF-000047055
UDI-DI: 06972976463032
Basic UDI-DI: B-06972976463032
Reference: S02B-020, S02B-050
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

06971100211365

1 test/kit, 2 tests/kit, 5 tests/kit, 10 tests/kit, 25 tests/kit, 50 tests/kit, 100 tests/kit.

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Wiz Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029590
UDI-DI: 06971100211365
Basic UDI-DI: B-06971100211365
Reference: A1C205020001, A1C205020002, A1C205020003, A1C205020004, A1C205020005, A1C205020006, A1C205020007.
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

OnSight™ Cortisol Quantitative Test

655-25-DB

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Affimedix, Inc.
Manufacturer SRN: US-MF-000053178
UDI-DI: 00850082432141
Basic UDI-DI: B-00850082432141
Reference: 655-25-DB
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 05.07.2026 11:05

Manufacturer products Authorised representative products Authorised representative actors View details