- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 30, 2026
805360894CML07024-25FXCap for Reagent Bottle 30 positions (500 Pcs) 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.
80536089445754CML07024A-500A(01)80536089445754
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201010185CHEMISTRY ANALYSERS - CONSUMABLESW0201020180AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIESIT-MF-000009556The 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.
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 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.805360894CML07024-25FXOn the marketCalibrated halogen lamp805360894CML07001G9On the marketCalibrated halogen lamp C805360894CML07001G9On the marketClosing lid for individual reagent position805360894ACC070476UOn the marketCore805360894ES000044ZOn the marketCore - Automated Immunochemistry Analyser805360894ES000044ZOn the marketNo certificate specifically references this device's Basic UDI-DI.