- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 5, 2026
805112287W050301029099XVContenitore da 20 ml, preriempito con 10ml di formaldeide al 8% e 10ml di soluzione fisiologica, con puntale rimovibile is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by TRACES S.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IT-MF-000028108(01)08051122870097
The 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.
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.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08051122870097Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
805112287W050301029099XVSECURBIOP F1010 SMARTUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W050301029099SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHERPrimary 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.805112287W050301029099XVOn the marketContenitore da 20 ml preriempito con formaldeide al 4%, puntale rimovibile805112287W050301029099XVOn the marketContenitore da 20 ml, preriempito con 10ml di formaldeide al 8% e 10ml di soluzione fisiologica805112287W050301029099XVOn the marketContenitore da 20 ml, preriempito con 10ml di formaldeide al 8% e 10ml di soluzione fisiologica.805112287W050301029099XVOn the marketContenitore da 20 ml, preriempito con 10ml di formaldeide al 8% rosa e 10ml di soluzione fisiologica805112287W050301029099XVOn the marketContenitore da 20 ml, preriempito con 10ml di formaldeide al 8% rosa e 10ml di soluzione fisiologica805112287W050301029099XVOn the market