- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Oct 22, 2025
B-0843528710097622047 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by BIOSYSTEMS S.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0843528710097622047(01)08435287100976
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010214GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)ES-MF-000000231Primary placement in Spain; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Apr 6, 2017 | Still on market |
| Cyprus | Apr 6, 2017 | Still on market |
| Italy | Apr 6, 2017 | Still on market |
| Poland | Apr 6, 2017 | Still on market |
| Portugal | Apr 6, 2017 | Still on market |
| Romania | Apr 6, 2017 | Still on market |
| Türkiye | Apr 6, 2017 | Still on market |
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 →Certificate health across this manufacturer's portfolio.
HX 1695779-1SupplementedNotified 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.
No certificate specifically references this device's Basic UDI-DI.