- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 18, 2026
B-06975447582157106-0066-01 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Igenesis(Shanghai)Co.,Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06975447582157B-06975447582157106-0066-01(01)06975447582157
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105041003PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTSNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Still on market |
CN-MF-000001552No 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.