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EUDAMED last updated this device on Dec 8, 2022
8588007083aquavivaHKOcean Standard is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Chirana Progress, s.r.o.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
085880070832098588007083aquavivaHKKV9500.824(01)08588007083209
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120618HYDROGYMNASTICS AND HYDROTHERAPY SYSTEMS1 warning recorded — scroll inside the panel to see all entries.
CW030No certificate specifically references this device's Basic UDI-DI.
Primary placement in Slovakia; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| SlovakiaPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Germany | 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 | |
| Türkiye | Still on market | |
| XI | Still on market |
SK-MF-000016090No 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.