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EUDAMED last updated this device on Mar 2, 2026
697518250F13005ZVG17 CLIA Kit (Chemiluminescence Immunoassay) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. 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.
06942293590872F13005(01)06942293590872
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102069001GASTRINCN-MF-000019511The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 |
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.
View in glossary →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.
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 →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 →697518250P116056JOn the marketFree Triiodothyronine CLIA Kit (Chemiluminescence Immunoassay)697518250F116042EOn the marketFree Triiodothyronine Determination Kit (Fluorescence Immunochromatographic Assay)697518250P116046GOn the marketGabapentin Panel Test Drugs of Abuse Test Kit697518250G127273KOn the marketGastrin Releasing Peptide Precursor CLIA Kit (Chemiluminescence Immunoassay)697518250F1300622On the marketGentamicin CLIA Kit (Chemiluminescence Immunoassay)697518250F11411ZWOn the marketNo certificate specifically references this device's Basic UDI-DI.
No 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.