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EUDAMED last updated this device on Jan 27, 2022
B-08719244951079Sapphire NC24 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by OrbusNeich Medical, B.V.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08719244951079B-08719244951079215-154-5(01)08719244951079
European Medical Device Nomenclature — the EU product classification assigned to this device.
C010401020101PTCA BALLOON DILATION CATHETERS1 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 3 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Nov 1, 2020 | Still on market |
| Spain | Dec 2, 2020 | Still on market |
| France | Jun 18, 2021 | Still on market |
NL-MF-000010907No 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.CE 706144