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EUDAMED last updated this device on May 14, 2026
B-06948309001295CU-10 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.. Placed on the EU market in Cyprus. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06948309001295B-06948309001295CU-10(01)06948309001295
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11040103PORTABLE ULTRASOUND SCANNERSNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Cyprus; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| CyprusPrimary placement | May 14, 2026 | Dec 31, 2028 |
CN-MF-000031019No 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.No. G1 071165 0013