EU → US Device Access

SIE AG, Surgical Instrument Engineering

CH-MF-000025018 · Switzerland · Port

SIE AG, Surgical Instrument Engineering is registered in the European database on medical devices as a manufacturer, with 62 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa57
Class IIb5

Most frequent device types declared: Procedure Pack Product Range, FEMTO LDV Z2, FEMTO LDV Z4, FEMTO LDV Z6, FEMTO LDV Z8, FEMTO Z8 NEO., Artificial Anterior Chamber (AAC) Product Range.

Among these devices, 53 are declared sterile, 5 active.

Authorised representative in the Union: DE-AR-000005638.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED62
Country of registrationSwitzerland
⚠️ 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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