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24 device results listed.

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06921807615218

CFMS LEPU-8880

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807615218
Basic UDI-DI: 692180760034EQ
Reference: CFMS LEPU-8880
EMDN: -
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

LEPU Fluo-800mini

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807612309
Basic UDI-DI: 692180760035ES
Reference: JY31 LEPU Fluo-800mini
EMDN: -
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer UAM1412

UAM1412

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611487
Basic UDI-DI: 692180764010F6
Reference: JY44UAM1412
EMDN: -
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

UAM1411

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611470
Basic UDI-DI: 692180764009FM
Reference: JY43UAM1411
EMDN: -
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Biochemical Analyzer MBM001

MBM001

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611463
Basic UDI-DI: 692180764008FK
Reference: JY42MBM001
EMDN: -
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin Analyzer HAM111

HAM111

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611456
Basic UDI-DI: 692180764007FH
Reference: JY45HAM111
EMDN: -
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer LEPU Quant 1600

LEPU Quant-Fluo 1600

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807605035
Basic UDI-DI: 692180760503F6
Reference: JY20LEPUQuant-Fluo1600
EMDN: -
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Gold Immunochromatograpic Assay Analyzer LEPU Quant 800

LEPU Quant 800

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807601136
Basic UDI-DI: 692180760113EM
Reference: JY04LEPU Quant 800
EMDN: -
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

06921807601006

LEPU FastRing FR 1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807601006
Basic UDI-DI: 692180760100EC
Reference: LEPU FastRing FR 1000
EMDN: -
EMDN description: HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System Lepgen-96

Lepgen-96

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600948
Basic UDI-DI: 692180760094FA
Reference: JY18Lepgen-96
EMDN: -
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence immunochromatography analyzer LEPU Quant-Fluo800

LEPU Quant-Fluo800

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600726
Basic UDI-DI: 692180760072EY
Reference: JY05LEPU Quant-Fluo 800
EMDN: -
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

06921807600306

CFMS LEPU-8800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600306
Basic UDI-DI: 692180760033EN
Reference: CFMS LEPU-8800
EMDN: -
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Thrombelastograph Heparinase Cup Test Kit(Viscosity Measuring)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600214
Basic UDI-DI: B-06921807600214
Reference: SH025
EMDN: -
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 01.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

Thrombelastograph General Cup Test Kit (Viscosity Measuring)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600221
Basic UDI-DI: B-06921807600221
Reference: SH0110
EMDN: -
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 01.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Monitoring Meters

IVD self-testing devicesNot specifiedOn the market

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600269
Basic UDI-DI: B-06921807600269
Reference: JY06 poctor800
EMDN: -
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 01.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

P2Y12 Receptor Platelet Aggregation Test Reagent Card (Turbidimetry)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600559
Basic UDI-DI: B-06921807600559
Reference: SH0810
EMDN: -
EMDN description: P2Y12 RECEPTOR
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 01.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

COX-1 Platelet Aggregation Test Reagent Card (Turbidimetry)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600566
Basic UDI-DI: B-06921807600566
Reference: SH0910
EMDN: -
EMDN description: AGGREGATION REAGENTS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 01.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807602669
Basic UDI-DI: B-06921807602669
Reference: GL01poctor800
EMDN: -
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 01.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Tests for Self-Testing

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807602942
Basic UDI-DI: B-06921807602942
Reference: CG3625
EMDN: -
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 01.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807610237
Basic UDI-DI: B-06921807610237
Reference: GL0825
EMDN: -
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 01.07.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details