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FOB Rapid Test Device (feces)

D050401D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474396
Basic UDI-DI: B-06976753474396
Reference: D050401D
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-fetoprotein (AFP) Assay Reagent Kit (CMIA)

C2KH017

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753470770
Basic UDI-DI: B-06976753470770
Reference: C2KH017
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

Protin induced by Vitamin K Absence or Antagonist -Ⅱ（PIVKA-Ⅱ）Assay Reagent Kit (CMIA)

C2KH014

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753470534
Basic UDI-DI: B-06976753470534
Reference: C2KH014
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (Beta2-MG) Assay Reagent Kit (CMIA)

C2KH009

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753470336
Basic UDI-DI: B-06976753470336
Reference: C2KH009
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron-Specific Enolase (NSE) Assay Reagent Kit (CMIA)

C2KH003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753470091
Basic UDI-DI: B-06976753470091
Reference: C2H003
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)

100 tests/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.
Manufacturer SRN: CN-MF-000055042
UDI-DI: 06976045540082
Basic UDI-DI: B-06976045540082
Reference: 100 tests/box
EMDN: W0102039010
EMDN description: MATRIX-METALLOPROTEINASES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)

40 tests/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.
Manufacturer SRN: CN-MF-000055042
UDI-DI: 06976045540075
Basic UDI-DI: B-06976045540075
Reference: 40 tests/box
EMDN: W0102039010
EMDN description: MATRIX-METALLOPROTEINASES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)

20 tests/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.
Manufacturer SRN: CN-MF-000055042
UDI-DI: 06976045540068
Basic UDI-DI: B-06976045540068
Reference: 20 tests/box
EMDN: W0102039010
EMDN description: MATRIX-METALLOPROTEINASES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

06976045540051

5 tests/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.
Manufacturer SRN: CN-MF-000055042
UDI-DI: 06976045540051
Basic UDI-DI: B-06976045540051
Reference: 5 tests/box
EMDN: W0102039010
EMDN description: MATRIX-METALLOPROTEINASES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)

1 test/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.
Manufacturer SRN: CN-MF-000055042
UDI-DI: 06976045540044
Basic UDI-DI: B-06976045540044
Reference: 1 test/box
EMDN: W0102039010
EMDN description: MATRIX-METALLOPROTEINASES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein (eCLIA)

2×100T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064437
Basic UDI-DI: B-06975984064437
Reference: 0320501404
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:21

Manufacturer products Authorised representative products Authorised representative actors View details

Laminin (LN) eCLIA

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063683
Basic UDI-DI: B-06975984063683
Reference: 692018
EMDN: W0102039006
EMDN description: LAMININ
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein (eCLIA)

2×50T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063362
Basic UDI-DI: B-06975984063362
Reference: 0320501402
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

Neuronen-Spezifische Enolase (eCLIA)

2×100 T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062952
Basic UDI-DI: B-06975984062952
Reference: 0320501604
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Neuronen-Spezifische Enolase (eCLIA)

2×50 T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062945
Basic UDI-DI: B-06975984062945
Reference: 0320501602
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975977120102

EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120102
Basic UDI-DI: B-06975977120102
Reference: NPC010-100
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

06975977120096

EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120096
Basic UDI-DI: B-06975977120096
Reference: NPC010-50
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

06975977120089

EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Genebiohealth Co., Ltd.
Manufacturer SRN: CN-MF-000046424
UDI-DI: 06975977120089
Basic UDI-DI: B-06975977120089
Reference: NPC010-10
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225923
Basic UDI-DI: B-06975424225923
Reference: DL248701C
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay Kit (Fluorescence Immunoassay)

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223523
Basic UDI-DI: B-06975424223523
Reference: DL248701
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details