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EUDAMED last updated this device on May 15, 2026
B-05206977000028Self Clear is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by BIOSYNEX. Placed on the EU market in Greece. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05206977000028ACO-01002(01)05206977000028
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102050206B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)1 warning recorded — scroll inside the panel to see all entries.
CW010Primary placement in EL; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ELPrimary placement | — | Still on market |
FR-MF-000014073V1 002187 0006Sterile
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 →Certificate health across this manufacturer's portfolio.
030/MDRIssuedG10 002187 0009IssuedNotified 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 →No certificate specifically references this device's Basic UDI-DI.