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EUDAMED last updated this device on Mar 4, 2022
B-08717853296918Sapphire II PRO 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.
08717853296918B-08717853296918232-203-5U(01)08717853296918
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 27 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jul 7, 2015 | Still on market |
| Austria | Nov 17, 2015 | Still on market |
| Belgium | Jul 13, 2015 | Still on market |
| Bulgaria | Oct 31, 2019 | Still on market |
| Cyprus | Oct 9, 2017 | Still on market |
| Czechia | Apr 12, 2018 | Still on market |
| Denmark | Sep 1, 2015 | Still on market |
| Estonia | Jul 26, 2018 | Still on market |
| EL | Feb 1, 2018 | Still on market |
| Spain | Nov 12, 2015 | Still on market |
| Finland | Feb 8, 2018 | Still on market |
| France | Aug 31, 2015 | Still on market |
| Hungary | Dec 16, 2015 | Still on market |
| Ireland | Jan 1, 2016 | Still on market |
| Italy | Jul 1, 2015 | Still on market |
| Lithuania | May 1, 2016 | Still on market |
| Luxembourg | Jan 1, 2016 | Still on market |
| Latvia | Jun 6, 2016 | Still on market |
| Netherlands | Jun 24, 2015 | Still on market |
| Norway | Jan 1, 2016 | Still on market |
| Poland | Jun 3, 2020 | Still on market |
| Portugal | May 29, 2017 | Still on market |
| Romania | Mar 14, 2019 | Still on market |
| Sweden | Nov 29, 2017 | Still on market |
| Slovenia | Oct 31, 2016 | Still on market |
| Slovakia | Mar 16, 2018 | Still on market |
| Türkiye | Sep 27, 2016 | 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 620000