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EUDAMED last updated this device on Aug 19, 2024
697440255CLIA_PreTriSolUGPre-Trigger Solution is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Virtue Diagnostics (Suzhou) Co., Ltd. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0697440255305812001082(01)06974402553058
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHER1 warning recorded — scroll inside the panel to see all entries.
For in vitro diagnostic use only.Avoid contacting with skin, eyes and clothing. In case of contact with any of these reagents, wash thoroughly with water and seek medical advice.
CN-MF-000013251The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Ireland; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | — | Still on market |
| Netherlands | — | 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 →No certificate specifically references this device's Basic UDI-DI.
697440255INST_VIRTUOSO6EOn the marketConcentrated Wash Buffer697440255CLIA_CWBuffer98On the marketConcentrated Wash Buffer697440255CLIA_CWBuffer98On the marketPre-Trigger Solution697440255CLIA_PreTriSolUGOn the marketSample Diluent A697440255CLIA_SAMPLEDILXCOn the marketSample Diluent A697440255CLIA_SAMPLEDILXCOn the marketNo 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.