EU → North America Device Access

Sixtem Life Srl

IT-MF-000022977 · Italy · Prato (PO)

Sixtem Life Srl is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa18

Among these devices, 13 are declared active.

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include BAZ0001, BEN0019, CRY0002, SUR0001, VER0001, VER1302.

European nomenclature codes declared: M9001, Y061203, M0599, M0412, V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED18
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 GTIN18
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entrySIXTEM LIFE SRL

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2013-05-14

Licence types: Single Device (2), Device Family (1).

Licensed under: VERRUKILL, RHAGADIL, CRYOKLEEN.

North American profile: Canada only. Sixtem Life Srl holds a Canadian licence but was not found in the U.S. register.

Notified body certificates

CertificateStatusExpiry
55191issued2027-12-22

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