- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Dec 21, 2022
805360894CML07020GDSpecimen collection screw cap tube 10.8 x 44 mm (2 mL) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Edif Instruments S.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
80536089407820CML07021C-001AIT-MF-000009556(01)80536089407820
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.
Placed on the market in Italy; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201010185CHEMISTRY ANALYSERS - CONSUMABLESW0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLESPrimary 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.
805360894CML07020GDOn the marketSpecimen collection cups, 3 mL805360894CML07020GDOn the marketSpecimen collection micro-tube, 0,75 mL805360894CML00716G8On the marketSpecimen collection tube 12mm x 55mm, 3 mL805360894CML07020GDOn the marketSpecimen collection tube 12mm x 75mm (4,5 mL)805360894CML07020GDOn the marketSpecimen collection tube 12mm x 85mm (5.5 mL)805360894CML07020GDOn 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.