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EUDAMED last updated this device on Jun 10, 2026
802816920CW010604020258LactoGen is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Eurospital Spa. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080281692057799241(01)08028169205779
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0106010499POLYMORPHISM TESTS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Nov 28, 2025 | Still on market |
IT-MF-000028468The 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 →802816920AW01050604013BOn the marketEu-Turbo Analyzer802816920AW02010608012JOn the marketHelori Urease802816920BW01050503013YOn the marketLactoGen Controls802816920CW010604020258On the marketLatex Removal Solution802816920AW02010608012JOn the marketXeliac Test Professional802816920BW01020603052YOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
V13 066267 0039IssuedV13 066267 0039 Rev. 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.
View in glossary →Notified 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.
View in glossary →