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195 device results listed.

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KEYU Automatic Urine Analysis System

KU-3000

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361917
Basic UDI-DI: B-06974735361917
Reference: KU-3000
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
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

KEYU Formed Element Analysis Calibrator

IVD generalNot specifiedOn the market

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361900
Basic UDI-DI: B-06974735361900
Reference: SED-CAL-1
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
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

KEYU Urine Analyzer Physical Multicontrol

IVD generalNot specifiedOn the market

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361894
Basic UDI-DI: B-06974735361894
Reference: UM-QC
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
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

KEYU Lactose Assay Kit (Enzymatic Method)

LAC-II

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361887
Basic UDI-DI: B-06974735361887
Reference: LAC-II
EMDN: W01010212
EMDN description: GALACTOSE
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

KEYU Lactose Assay Kit (Enzymatic Method)

LAC-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361870
Basic UDI-DI: B-06974735361870
Reference: LAC-I
EMDN: W01010212
EMDN description: GALACTOSE
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

KEYU Norovirus Antigen Test Kit (Colloidal gold method)

NV-II

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361863
Basic UDI-DI: B-06974735361863
Reference: NV-II
EMDN: W0105040616
EMDN description: NOROVIRUS
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

KEYU Norovirus Antigen Test Kit (Colloidal gold method)

NV-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361856
Basic UDI-DI: B-06974735361856
Reference: NV-I
EMDN: W0105040616
EMDN description: NOROVIRUS
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

KEYU Urine Analysis Specific Gravity Calibrator

SG-CAL-Ⅰ

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361542
Basic UDI-DI: B-06974735361542
Reference: SG-CAL-Ⅰ
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
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

KEYU Urine Analysis Specific Gravity Quality Control

SG-QC-Ⅰ

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361535
Basic UDI-DI: B-06974735361535
Reference: SG-QC-Ⅰ
EMDN: W0101050207
EMDN description: URINE CONTROLS
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

KEYU Urine Chemistry QC

C-UC-3

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361382
Basic UDI-DI: B-06974735361382
Reference: C-UC-3
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Chemistry QC

C-UC-2

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361375
Basic UDI-DI: B-06974735361375
Reference: C-UC-2
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Chemistry QC

C-UC-1

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361368
Basic UDI-DI: B-06974735361368
Reference: C-UC-1
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Dry Chemistry Strip

C-14

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361351
Basic UDI-DI: B-06974735361351
Reference: C-14
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Dry Chemistry Strip

C-12

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361344
Basic UDI-DI: B-06974735361344
Reference: C-12
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Sediment QC

C-US-4

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361337
Basic UDI-DI: B-06974735361337
Reference: C-US-4
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Sediment QC

C-US-3

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361320
Basic UDI-DI: B-06974735361320
Reference: C-US-3
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Sediment QC

C-US-2

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361313
Basic UDI-DI: B-06974735361313
Reference: C-US-2
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Sediment QC

C-US-1

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361306
Basic UDI-DI: B-06974735361306
Reference: C-US-1
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU FOB Quality Control

FOB-QC-III

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361276
Basic UDI-DI: B-06974735361276
Reference: FOB-QC-III
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Feces Sediment Quality Control

FFE-QC-E

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361269
Basic UDI-DI: B-06974735361269
Reference: FFE-QC-E
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details