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EUDAMED last updated this device on May 26, 2025
805714973BIOMECHANICSW4F293491005400 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Health and Fashion Shoes Italia SpA. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08004373050299805714973BIOMECHANICSW4F293491005400(01)08004373050299
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.
Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
IT-MF-000038685No 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.