EU → North America Device Access

ITALRAY s.r.l.

IT-MF-000014620 · Italy · Scandicci

ITALRAY s.r.l. is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb14

Most frequent device types declared: SRD+IR700-A.

Among these devices, 14 are declared active.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include AMR+IR303-B, AMR+IR313-A, AMR+IR313-B, SRD+IR505-B, SRD+IR520-A, SRD+IR520-B.

European nomenclature codes declared: Z119007, Z11039016, Z11030702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN14
Found in the U.S. device database0
Share0.0 %

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: Neither register. ITALRAY s.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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