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EUDAMED last updated this device on Sep 20, 2022
B-08719326450131Transpara is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by ScreenPoint Medical. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08719326450131B-08719326450131Version 1.7.0 and 1.7.1(01)08719326450131
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11030292MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARENo certificate specifically references this device's Basic UDI-DI.
Primary placement in Netherlands; available across 16 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Iceland | Still on market | |
| Italy | Still on market | |
| Luxembourg | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Sweden | Still on market | |
| XI | Still on market |
NL-MF-000000241No 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.2181543CE01