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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

Ketone Test Strips

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807610275
Basic UDI-DI: B-06921807610275
Reference: GL0625
EMDN: -
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
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

Uric Acid Test Strip

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807610282
Basic UDI-DI: B-06921807610282
Reference: GL0425
EMDN: -
EMDN description: URIC ACID
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, Ketone and Uric Acid Meters

IVD self-testing devicesNot specifiedOn the market

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611326
Basic UDI-DI: B-06921807611326
Reference: JY15Poctor M3101
EMDN: -
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
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: 06921807612101
Basic UDI-DI: B-06921807612101
Reference: GL0810
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

Diagnostic Kit for Methylated Genes of Gastric Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703930109
Basic UDI-DI: 697070393GAC00182
Reference: GAC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 30.06.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703930093
Basic UDI-DI: 697070393BRC001BU
Reference: BRC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 30.06.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details