EU Manufacturer
🇨🇳 China
Active
BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
SRN: CN-MF-000019125
·
No.7, Yan Qi He, Xi Yi Rd., Huai Rou District,, 101407 Beijing, China
Basic UDI-DIs
43
Total Devices
43
On Market
43
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- No.7, Yan Qi He, Xi Yi Rd., Huai Rou District,, 101407 Beijing, China
- [email protected]
- Phone
- +86 133 1150 3327
- Website
- en.keweidiagnostic.com
Regulatory Overview
Regulation
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Eu Ivdd
43
Classification
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Eu Ivd General
42
Eu Ivd Self Testing
1
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Expired / Withdrawn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 III Section 6 | 1434-IVDD-238/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| ANTI-MÛLLERIAN HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |
| BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) | EU IVDD | Eu Ivd General | On Market | 0 |
| BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATINE KINASE - MB MASS (IC) | EU IVDD | Eu Ivd General | On Market | 0 |
| GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) | EU IVDD | Eu Ivd General | On Market | 0 |
| H. PYLORI ANTIGEN DETECTION | EU IVDD | Eu Ivd General | On Market | 0 |
| IMMUNOCHEMISTRY REAGENTS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| IMMUNOCHEMISTRY REAGENTS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| IMMUNOCHEMISTRY REAGENTS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| IMMUNOCHEMISTRY REAGENTS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| IMMUNOCHEMISTRY REAGENTS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| IMMUNOCHEMISTRY REAGENTS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| INFECTIOUS IMMUNOLOGY - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| MYOGLOBIN | EU IVDD | Eu Ivd General | On Market | 0 |
| NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2) | EU IVDD | Eu Ivd General | On Market | 0 |
| RENAL METABOLISM TESTS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| TROPONIN I/T | EU IVDD | Eu Ivd General | On Market | 0 |
| TROPONIN I/T | EU IVDD | Eu Ivd General | On Market | 0 |
| TUMOUR MARKERS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |