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EUDAMED last updated this device on Jun 9, 2026
880911590IHM0005MM5CLOVER A1c Expert Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by OSANG Healthcare Co., Ltd. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08809115901446OHHS03A(01)08809115901446
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201060101GLYCOSILATED HEMOGLOBIN DEVICEs1 warning recorded — scroll inside the panel to see all entries.
KR-MF-000032605No 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.The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Czechia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Jun 3, 2026 | 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 →No certificate specifically references this device's Basic UDI-DI.
B-04260235110325On the marketCLOVER A1c Analyzer880911590IGM0023MLQOn the marketCLOVER A1c Analyzer880911590IGM0023MLQOn the marketCLOVER A1c Expert Analyzer880911590IHM0005MM5On the marketCLOVER A1c Expert Analyzer880911590IHM0005MM5On the marketCLOVER A1c Expert Analyzer880911590IHM0005MM5On the market