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EUDAMED last updated this device on Apr 30, 2026
B-03760124132052POLARIS® 24 ADJUSTABLE VALVE / ANTECHAMBER is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by SOPHYSA. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
03760124132052B-03760124132052SPV24A-2010(01)03760124132052
European Medical Device Nomenclature — the EU product classification assigned to this device.
N01038099INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER5 warnings recorded — scroll inside the panel to see all entries.
CW009CW001CW026CW011CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Oct 1, 2019 | Still on market |
FR-MF-000002870No 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.35948B-03760124130980On the marketSOPHY® SM8 KIT PREATTACHEDB-03760124131116On the marketCATHETER EXTENSION CABLE376012413PSOEC30000F6On the marketCATHETER PASSER DISPOSABLE, 30 CM + SHEATHB-03760124131840On the marketCATHETER PASSER DISPOSABLE, 45 CM + SHEATHB-03760124131857On the market