EU → North America Device Access

DELTA P S.R.L.

IT-MF-000019346 · Italy · ROSATE

DELTA P S.R.L. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb5

Most frequent device types declared: DMDP001002, DMDP001003, DMDP001004.

Among these devices, 5 are declared active.

Catalogue references include 8510A-2290, 8510AN-2290, 8535A-2290, 8535AN-2290, 9763-VIT38.

European nomenclature codes declared: Z120309.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. DELTA P S.R.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
063/MDRsupplemented2027-11-20

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