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EUDAMED last updated this device on May 22, 2026
69383846TY004XUPOCT HbA1c Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Labnovation Technologies, Inc.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06938384641455L-800502(01)06938384641455
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.
CW010Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
CN-MF-000015953The 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 →B-06938384622041On the marketPOCT HbA1c Analyzer69383846TY004XUOn the marketPOCT HbA1c Analyzer69383846TY004XUOn the marketSARS-CoV-2 Antigen and Influenza A/B Rapid Test Kit (Immunochromatography)B-06938384622096On the marketSARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)B-06938384622089On the marketSARS-CoV-2/Flu A/Flu B/RSV/ADV Antigen Rapid Test Kit (Immunochromatography)B-06938384622119On the marketNo 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.