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EUDAMED last updated this device on Jun 17, 2025
037004697E2012N4Anatomical Gel Filled Mammary Sizers is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by EUROSILICONE SAS. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
03700469711635037004697E2012N4AS-MR1/195(01)03700469711635
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.
P0699BREAST IMPLANTS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW018No certificate specifically references this device's Basic UDI-DI.
Primary placement in France; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Feb 12, 2025 | Still on market |
| Austria | Feb 12, 2025 | Still on market |
| Belgium | Feb 12, 2025 | Still on market |
| Bulgaria | Feb 12, 2025 | Still on market |
| Cyprus | Feb 12, 2025 | Still on market |
| Czechia | Feb 12, 2025 | Still on market |
| Germany | Feb 12, 2025 | Still on market |
| Denmark | Feb 12, 2025 | Still on market |
| Estonia | Feb 12, 2025 | Still on market |
| EL | Feb 12, 2025 | Still on market |
| Spain | Feb 12, 2025 | Still on market |
| Finland | Feb 12, 2025 | Still on market |
| Croatia | Feb 12, 2025 | Still on market |
| Hungary | Feb 12, 2025 | Still on market |
| Ireland | Feb 12, 2025 | Still on market |
| Iceland | Feb 12, 2025 | Still on market |
| Italy | Feb 12, 2025 | Still on market |
| Liechtenstein | Feb 12, 2025 | Still on market |
| Lithuania | Feb 12, 2025 | Still on market |
| Luxembourg | Feb 12, 2025 | Still on market |
| Latvia | Feb 12, 2025 | Still on market |
| Malta | Feb 12, 2025 | Still on market |
| Netherlands | Feb 12, 2025 | Still on market |
| Norway | Feb 12, 2025 | Still on market |
| Poland | Feb 12, 2025 | Still on market |
| Portugal | Feb 12, 2025 | Still on market |
| Romania | Feb 12, 2025 | Still on market |
| Sweden | Feb 12, 2025 | Still on market |
| Slovenia | Feb 12, 2025 | Still on market |
| Slovakia | Feb 12, 2025 | Still on market |
| Türkiye | Feb 12, 2025 | Still on market |
| XI | Feb 12, 2025 | Still on market |
FR-MF-000008947No 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.037004697E2012N4On the marketAnatomical Gel Filled Mammary Sizers037004697E2012N4On the marketAnatomical Gel Filled Mammary Sizers037004697E2012N4On the marketAnatomical Gel Filled Mammary Sizers037004697E2012N4On the marketAnatomical Gel Filled Mammary Sizers037004697E2012N4On the market