EU → North America Device Access

MEDES S.r.l.

IT-MF-000025275 · Italy · Brugherio

MEDES S.r.l. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb8
Class IIa3

Most frequent device types declared: Anesthetic gases and/or nitric oxide mixtures scavenging systems (AGSS, Compressed gas distribution system, Medical gas/vacuum pipeline systems.

Among these devices, 11 are declared active.

Devices declared under this manufacturer

Catalogue references include Air for driving surgical tools distribution system, Medical Nitrous oxide distribution system, Medical air distribution system, Medical device Argon distribution system, Medical oxygen distribution system, System powered by blowers.

European nomenclature codes declared: Z120309.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. MEDES S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
042-00-02-MDRsupplemented2029-02-19

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