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EUDAMED last updated this device on Jul 27, 2026
1912013223A290-006VWOptimization mix for Lyso Triplex is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by ARCHImedline GmbH. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
09120132230050A290-006(01)09120132230050
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01019099CLINICAL CHEMISTRY REAGENTS - OTHER3 warnings recorded — scroll inside the panel to see all entries.
AT-MF-000037501The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Austria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Jul 9, 2026 | Still on market |
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 →1912013223M002G7On the marketMobile Phase 0021912013223M002G7On the marketMobile Phase for PEth from whole blood1912013223A371-001VNOn the marketOptimization mix for PEth from whole blood1912013223A371-006VYOn the marketPEth from whole blood1912013223A371EMOn the marketPrecipitation solution with internal standard for PEth from whole blood1912013223A371-010VPOn the marketCertificate health across this manufacturer's portfolio.
IQMS/00010/0v002SupplementedNotified 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.