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Thymidine Kinase 1 Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Please see the IFU.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hoyotek Biomedical Co.,Ltd.
Manufacturer SRN: CN-MF-000003570
UDI-DI: 06974738205201
Basic UDI-DI: B-06974738205201
Reference: IF18-01-40
EMDN: W0102039008
EMDN description: THYMIDINE KINASE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Thymidine Kinase 1 Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Please see the IFU.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hoyotek Biomedical Co.,Ltd.
Manufacturer SRN: CN-MF-000003570
UDI-DI: 06974738205195
Basic UDI-DI: B-06974738205195
Reference: IF18-01-20
EMDN: W0102039008
EMDN description: THYMIDINE KINASE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892176
Basic UDI-DI: B-06974674892176
Reference: 18-02-0047
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892114
Basic UDI-DI: B-06974674892114
Reference: 18-02-0041
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101455
Basic UDI-DI: B-06974671101455
Reference: DR-PS-A002
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101448
Basic UDI-DI: B-06974671101448
Reference: DR-PS-A001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:08

Manufacturer products Authorised representative products Authorised representative actors View details

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101417
Basic UDI-DI: B-06974671101417
Reference: DR-CM-A011
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:08

Manufacturer products Authorised representative products Authorised representative actors View details

250 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100519
Basic UDI-DI: B-06974671100519
Reference: DR-CLIA-CM-B005
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100502
Basic UDI-DI: B-06974671100502
Reference: DR-CLIA-CM-A005
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

250 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100397
Basic UDI-DI: B-06974671100397
Reference: DR-CLIA-CM-B001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100380
Basic UDI-DI: B-06974671100380
Reference: DR-CLIA-CM-A001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100069
Basic UDI-DI: B-06974671100069
Reference: DR-CM-A016
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:06

Manufacturer products Authorised representative products Authorised representative actors View details

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100014
Basic UDI-DI: B-06974671100014
Reference: DR-CM-A001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:06

Manufacturer products Authorised representative products Authorised representative actors View details

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303391
Basic UDI-DI: B-06974566303391
Reference: TFO-609
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin and Transferrin Rapid Test

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303339
Basic UDI-DI: B-06974566303339
Reference: THT-629
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Hungary
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein (AFP) Test Kit (Homogeneous Chemiluminescence Immunoassay)

Alpha-Fetoprotein (AFP) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524062360
Basic UDI-DI: B-06974524062360
Reference: HCLIA15139
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for β2-microglobulin (β2-MG) (Time-resolved Fluorescence Immunochromatographic Assay)

Diagnostic Kit for β2-microglobulin (β2-MG) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003342
Basic UDI-DI: B-06974521003342
Reference: SUPF068025
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)

Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003243
Basic UDI-DI: B-06974521003243
Reference: SUPF034025
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:34

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay kit CLIA

AFP Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001003
Basic UDI-DI: B-06974521001003
Reference: SUPM066072
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay kit CLIA

AFP Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000990
Basic UDI-DI: B-06974521000990
Reference: SUPM066036
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details