Malvestio Spa

IT-MF-000013307 · Italy · Villanova di Camposampiero (PD)

Malvestio Spa is registered in the European database on medical devices as a manufacturer, with 279 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa	279

Most frequent device types declared: 32945, 32960, 32990, 329645C, 32960C, 329XXX, 329XXX_C, CF29XXX, 3900B, 3900SB, 3905B, 3905SB, 3960B, 3960SB, 3965B, 3965SB, 334500, 334505, 334550, 334555, 334820, 334840, 3700, 3705, 3710, 3715, 3720, 3725, 304700, 304700A, 304700XL, 304700XLA, 304720, 304740.

Among these devices, 67 are declared active, 22 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment register	Not found in the FDA register
Devices in EUDAMED	279
Country of registration	Italy

⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

Certificate	Status	Expiry
`199/MDR`	supplemented	2029-12-09

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