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EUDAMED last updated this device on Feb 19, 2026
506065486CYP2C19-CTRL01RTGenedrive® CYP2C19 Control Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Genedrive Diagnostics Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05060654860660CYP2C19-CTRL10-TR(01)05060654860660
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0106030101CYP 450 - INDIVIDUAL TEST5 warnings recorded — scroll inside the panel to see all entries.
CW009CW010CW032CW267CW007GB-MF-000012810The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Türkiye; available across 1 country total.
Placed on the market in Türkiye; per-country availability dates not published.
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 →506065486CYP2C19-CTRL01RTOn the marketGenedrive® CYP2C19 Control Kit506065486CYP2C19-CTRL01RTOn the marketGenedrive® CYP2C19 Control Kit506065486CYP2C19-CTRL01RTOn the marketGenedrive® System506065486GS-00X2FOn the marketGenedrive® CYP2C19 Collection Kit506065486CK-CYP2C19-019LOn the marketCertificate health across this manufacturer's portfolio.
ITDA/00006/0v003AmendedIQMS/00016/0v001IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.