EU → US Device Access

Medicel AG

CH-MF-000016652 · Switzerland · Altenrhein

Medicel AG is registered in the European database on medical devices as a manufacturer, with 318 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa318

Most frequent device types declared: IOL injectors, SMS390S.

Among these devices, 318 are declared sterile, 107 active.

Authorised representative in the Union: DE-AR-000015844.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDICEL AG (CH) · FDA 9681862
Devices in EUDAMED318
Country of registrationSwitzerland

Notified body certificates

CertificateStatusExpiry
2073GB448241112supplemented2027-07-26

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