- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Sep 11, 2026
B-08050593875044NEW TEST - 2 PZ is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by Logiter One Srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080505938750445007(01)08050593875044
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POCPrimary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
IT-MF-000037076V11082880001CLI1082880002Sterile
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 →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.805059387INLOG2023F8On the marketMY OTOBRIAN - Coni auricolari805059387CLOG022022DROn the marketNEW EASY - 1 TESTB-08050593875037On the marketODOBEN805059387CLOG022022DROn the marketOTO CLEAN 2 - CONI AURICOLARI805059387CLOG022022DROn the marketOTO CLEAN 4 - CONI AURICOLARI805059387CLOG022022DROn the market