EU → North America Device Access

Polaroid Therapeutics AG

CH-MF-000049447 · Switzerland · Schlieren

Polaroid Therapeutics AG is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb14

Most frequent device types declared: Fiber_20.

Among these devices, 14 are declared sterile.

Authorised representative in the Union: Qualrep Services B.V..

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include 205131010, 205152005, 206024505, 206041005, 40511813, 40511815.

European nomenclature codes declared: M040404.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
Country of registrationSwitzerland

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

Device-level evidence

Devices with a numeric GTIN14
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. Polaroid Therapeutics AG was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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