EU → North America Device Access

Rand S.p.A.

IT-MF-000013507 · Italy · Medolla

Rand S.p.A. is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa11
Class IIb1

Most frequent device types declared: R5100075, R9900071, R9900086, R9900088, R9900089.

Among these devices, 11 are declared sterile, 1 active.

Devices declared under this manufacturer

Catalogue references include R9900071, R9900086, R9900089, R9900101, R9900119, R9900122.

European nomenclature codes declared: Z1204021585, A0601010402, Z1204021501.

United States market access

FDA establishment registerRegistered with FDA
Matched entryRAND S.p.A. (IT) · FDA 3003793891
Devices in EUDAMED12
Country of registrationItaly

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Rand S.p.A. is registered in the United States but was not found in the Canadian register.

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