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24 device results listed.

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06921807600306

CFMS LEPU-8800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional 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: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 04.08.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

GO S1101 GL0810

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807612101
Basic UDI-DI: B-06921807612101
Reference: GL0810
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose, Ketone and Uric Acid Meters

PoctorM3101

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611326
Basic UDI-DI: B-06921807611326
Reference: JY15Poctor M3101
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Uric Acid Test Strip

UAS1100 GL0425

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807610282
Basic UDI-DI: B-06921807610282
Reference: GL0425
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Ketone Test Strips

KT S1101 GL0625

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807610275
Basic UDI-DI: B-06921807610275
Reference: GL0625
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

GO S1101 GL0825

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807610237
Basic UDI-DI: B-06921807610237
Reference: GL0825
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

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

CG3610

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807602942
Basic UDI-DI: B-06921807602942
Reference: CG3625
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

Poctor 800

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807602669
Basic UDI-DI: B-06921807602669
Reference: GL01poctor800
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

COX-1 Platelet Aggregation Test Reagent Card (Turbidimetry)

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600566
Basic UDI-DI: B-06921807600566
Reference: SH0910
EMDN: W0103020401
EMDN description: AGGREGATION REAGENTS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

P2Y12 Receptor Platelet Aggregation Test Reagent Card (Turbidimetry)

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600559
Basic UDI-DI: B-06921807600559
Reference: SH0810
EMDN: W0103020407
EMDN description: P2Y12 RECEPTOR
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Monitoring Meters

Poctor 800

IVD self-testing devicesIVDDOn the marketInstrumentMicrobial substancesProfessional testingSelf testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600269
Basic UDI-DI: B-06921807600269
Reference: JY06 poctor800
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Thrombelastograph General Cup Test Kit (Viscosity Measuring)

10 tests / box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600221
Basic UDI-DI: B-06921807600221
Reference: SH0110
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Thrombelastograph Heparinase Cup Test Kit(Viscosity Measuring)

5 test / box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600214
Basic UDI-DI: B-06921807600214
Reference: SH025
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

06921807615218

CFMS LEPU-8880

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional 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: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

LEPU Fluo-800mini

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional 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: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer UAM1412

UAM1412

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611487
Basic UDI-DI: 692180764010F6
Reference: JY44UAM1412
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

UAM1411

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611470
Basic UDI-DI: 692180764009FM
Reference: JY43UAM1411
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Biochemical Analyzer MBM001

MBM001

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611463
Basic UDI-DI: 692180764008FK
Reference: JY42MBM001
EMDN: W0201010102
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: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin Analyzer HAM111

HAM111

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611456
Basic UDI-DI: 692180764007FH
Reference: JY45HAM111
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

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 diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807605035
Basic UDI-DI: 692180760503F6
Reference: JY20LEPUQuant-Fluo1600
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details