EU Manufacturer
๐จ๐ณ China
Active
Beijing Lepu Medical Technology Co., Ltd.
SRN: CN-MF-000033011
ยท
Building 7-1, No. 37 Chaoqian Road, Changping District, 102200 Beijing P.R. China, 102200 Beijing, China
Basic UDI-DIs
16
Total Devices
16
On Market
16
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
3
Basic Information
- Address
- Building 7-1, No. 37 Chaoqian Road, Changping District, 102200 Beijing P.R. China, 102200 Beijing, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdr
10
Eu Ivdd
6
Classification
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Eu Ivd Class A
10
Eu Ivd Self Testing
6
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2062714-1 | TรV Rheinland LGA Products GmbH | May 19, 2022 |
Market Presence
Devices from this manufacturer are available in 3 countries across Europe.
๐ซ๐ท France
๐ฎ๐ธ Iceland
๐ต๐ฑ Poland
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Blood Glucose Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Blood Glucose Test Strips | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Blood Glucose, Ketone and Uric Acid Meters | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Colloidal Gold Immunochromatograpic Assay Analyzer LEPU Quant 800 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Dry Biochemical Analyzer MBM001 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| FastRing Automatic Aggregometer-FR1000 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Fluorescence Immunoassay Analyzer LEPU Quant 1600 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Fluorescence immunochromatography analyzer LEPU Quant-Fluo800 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Glycated Hemoglobin Analyzer HAM111 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Ketone Test Strips | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Real-Time PCR System Lepgen-96 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| SARS-COV-2 Antigen Rapid Tests for Self-Testing | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Thrombelastography Analyzer CFMS LEPU-8800 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Uric Acid Test Strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Urine Analyzer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Urine Analyzer UAM1412 | EU IVDR | Eu Ivd Class A | On Market | 0 |