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EUDAMED last updated this device on Jul 16, 2026
805551056cont_camp_istoKVFILM A BARRIERA OSSIGENO 140 x 270 mm is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Kaltek S.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080555105620903175(01)08055510562090
European Medical Device Nomenclature — the EU product classification assigned to this device.
W050301029099SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHERPrimary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
IT-MF-000019573The 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 →No certificate specifically references this device's Basic UDI-DI.
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 →Certificate health across this manufacturer's portfolio.
IT348898IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
0425-MDR-030116-00IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
805551056enteroclismaEMOn the marketENTEROCLISMA CONTENITORE 1.000 ml805551056enteroclismaEMOn the marketENTEROCLISMA CONTENITORE 2.000 ml805551056enteroclismaEMOn the marketFILM A BARRIERA OSSIGENO 270 x 270 mm805551056cont_camp_istoKVOn the marketGHIACCIO IN GEL KRYO GEL 11 x 26 cm805551056kryogelDEOn the marketGHIACCIO IN GEL KRYO GEL 14 x 18 cm805551056kryogelDEOn the market