EU → US Device Access

ELECTROCHEM SILICONES LTD / ELECTROCHEM SILICONES ΜΟΝΟΠΡΟΣΩΠΗ ΕΠΕ

GR-MF-000020994 · Greece · THESSALONIKI SINDOS

ELECTROCHEM SILICONES LTD / ELECTROCHEM SILICONES ΜΟΝΟΠΡΟΣΩΠΗ ΕΠΕ is registered in the European database on medical devices as a manufacturer, with 169 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa169

Most frequent device types declared: Silicone tubing for suction and drainage, Silicone RO tubing for suction, Elastic yellow tubing for drainage, Plastic straight tubing for suction, Plastic bubble tubing for suction.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED169
Country of registrationGreece
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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