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EUDAMED last updated this device on Feb 3, 2026
805768091FassstDNA_01SUFassst DNA Releaser is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Clonit srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08057680911319EMR057050(01)08057680911319
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUSPrimary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
IT-MF-000022196The 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.
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.
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.805768091FVG1691_M01CHOn the marketDuplicα Real Time HLA-B*5701 EZ Type KitB-08057680910442On the marketDuplicα RealTime Mix & Match Factor V G1691A Kit QS805768091FVG1691_M01CHOn the marketGluten DQuick DresolutionB-08057680910688On the marketGluten DQuick DResolutionB-08057680910695On the marketGluten DQuick DResolution v4805768091GlutenDQ_02E3On the market