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EUDAMED last updated this device on May 11, 2026
B-04058863304069Edinburgh NRP pack "BIOLINE COATING" Edinburgh Royal Infirmary Edinburgh - GBR is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by Maquet Cardiopulmonary GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04058863304069B-04058863304069701076674(01)04058863304069
European Medical Device Nomenclature — the EU product classification assigned to this device.
C03010301CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)1 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 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Denmark | Still on market | |
| Estonia | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Hungary | Still on market | |
| Ireland | Still on market | |
| Iceland | Still on market | |
| Italy | Still on market | |
| Liechtenstein | Still on market | |
| Lithuania | Still on market | |
| Luxembourg | Still on market | |
| Latvia | Still on market | |
| Malta | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Sweden | Still on market | |
| Slovenia | Still on market | |
| Slovakia | Still on market | |
| Türkiye | Still on market | |
| XI | Still on market |
DE-MF-000020091Certificate health across this manufacturer's portfolio.
G15 067154 0016Issued50008-16-10405886357664FEOn the market016061 Holder arm405886357664FEOn the market016062 Holder for Oxygenator405886357664FEOn the market016062 Holder for Oxygenator405886357664FEOn the marketArt. HLS cannula OD = 13 Fr (4.3 mm) 3/8" connector with LL, insertion length 15 cmB-04037691736587On the market