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EUDAMED last updated this device on Mar 4, 2026
697518250P1140568Vancomycin Determination Kit (Fluorescence Immunochromatographic Assay) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Beijing Diagreat Biotechnologies Co., Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06942293580521P11405CN-MF-000019511No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.(01)06942293580521
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Italy; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Dec 1, 2023 | Dec 1, 2029 |
| Poland | Dec 1, 2023 | Dec 1, 2029 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102080319VANCOMYCINPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →697518250F1140628On the marketValproic Acid Determination Kit (Fluorescence Immunochromatographic Assay)697518250P114076COn the marketVancomycin CLIA Kit (Chemiluminescence Immunoassay)697518250F1140322On the marketVedolizumab CLIA Kit (Chemiluminescence Immunoassay)697518250F114462LOn the marketVedolizumab CLIA Kit (Chemiluminescence Immunoassay)697518250F114462LOn the marketVedolizumab Determination Kit (Fluorescence Immunochromatographic Assay)697518250P1142166On the marketNo certificate specifically references this device's Basic UDI-DI.