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EUDAMED last updated this device on May 14, 2026
B-0697051408101406970514081014B-06970514081014FAPCR-50(01)06970514081014
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105060401ASPERGILLUS - NA REAGENTS1 warning recorded — scroll inside the panel to see all entries.
CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
CN-MF-000027997No 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.B-06970514080413On the marketAspergillus Galactomannan Detection Kit (CLIA)B-06970514080604On the marketAspergillus IgM Antibody Detection K-Set(CLIA)B-06970514080635On the marketAspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time PCR)B-06970514080994On the marketCandida auris Molecular Detection Kit (Real-time PCR)B-06970514081076On the market