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19 device results listed.

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Novel Coronavirus (2019-nCoV) Antigen Rapid Test

1 test/kit

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagent

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: D-NA7S
Basic UDI-DI: B-NA7S
Reference: NA
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 05:19

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

06973914383573

100 TEST/KIT

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914383573
Basic UDI-DI: B-06973914383573
Reference: H201.02.110C5.010
EMDN: W0102069013
EMDN description: PROCALCITONIN
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

06973914383474

100 TEST/KIT

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914383474
Basic UDI-DI: B-06973914383474
Reference: H201.02.148C1.010
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
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

06973914383146

100 TEST/KIT （CALIBRATION 6×1）

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914383146
Basic UDI-DI: B-06973914383146
Reference: H201.02.021C2.610
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
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

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

06973914382095

100 TEST/KIT

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914382095
Basic UDI-DI: B-06973914382095
Reference: H201.02.031C5.010
EMDN: W01021304
EMDN description: MYOGLOBIN
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

06973914382088

100 TEST/KIT

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914382088
Basic UDI-DI: B-06973914382088
Reference: H201.02.032C5.010
EMDN: W01021306
EMDN description: TROPONIN I/T
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

06973914382071

100 TEST/KIT

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914382071
Basic UDI-DI: B-06973914382071
Reference: H201.02.033C5.010
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
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

06973914381661

100 TEST/KIT

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914381661
Basic UDI-DI: B-06973914381661
Reference: H201.02.140C1.020
EMDN: W01010127
EMDN description: PEPSIN
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

06973914381654

100 TEST/KIT

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914381654
Basic UDI-DI: B-06973914381654
Reference: H201.02.142C1.020
EMDN: W01010127
EMDN description: PEPSIN
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

06973914381647

100 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914381647
Basic UDI-DI: B-06973914381647
Reference: H201.02.019C1.G10
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
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

06973914381630

100 TEST/KIT

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914381630
Basic UDI-DI: B-06973914381630
Reference: H201.02.072A1.010
EMDN: W0102070102
EMDN description: FERRITIN
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

06973914380947

500 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914380947
Basic UDI-DI: B-06973914380947
Reference: H201.02.089C6.020
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
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

06973914380442

100 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914380442
Basic UDI-DI: B-06973914380442
Reference: H201.02.107C1.01X
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
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

06973914380435

100 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914380435
Basic UDI-DI: B-06973914380435
Reference: H201.02.021C1.01X
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
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

06973914380411

100 TEST/KIT

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Bioscience Diagnostic Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023301
UDI-DI: 06973914380411
Basic UDI-DI: B-06973914380411
Reference: H201.02.089C1.010
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 17:46

Manufacturer products Authorised representative products Authorised representative actors View details