EU → North America Device Access

STERIFAST - STERILIZATION & DISINFECTION SYSTEMS LDA.

PT-MF-000012426 · Portugal · BOTICAS

STERIFAST - STERILIZATION & DISINFECTION SYSTEMS LDA. is registered in the European database on medical devices as a manufacturer, with 163 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa158
Class IIb5

Most frequent device types declared: ECOPLASMA E110 1SD-B, ECOPLASMA E110 2SD-B, ECOPLASMA E160 2SD-B, ECOPLASMA E50 1SD-B, ECOPLASMA E50 2SD-B.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Showing 12 of 163 declared devices.

Catalogue references include 330601007, 330602015, 330602027, 330602029, 330602030, 330602047.

European nomenclature codes declared: S01020101, S01010101, S9099, S010301, S01020102, S01020201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED163
Country of registrationPortugal

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

Device-level evidence

Devices with a numeric GTIN163
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. STERIFAST - STERILIZATION & DISINFECTION SYSTEMS LDA. was not found in either the U.S. or the Canadian register.

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