EU → North America Device Access

RELIFE S.r.l.

IT-MF-000007611 · Italy · Firenze

RELIFE S.r.l. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: DLP011, DLP033.

Devices declared under this manufacturer

Catalogue references include 51S004, 53S004, ZS0345, ZS0347, ZS0348, ZV0361.

European nomenclature codes declared: M9002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. RELIFE S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
MDR 00138-Aissued2030-07-10

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