EU → North America Device Access

C LindheXtend AB

SE-MF-000005639 · Sweden · Halmstad

C LindheXtend AB is registered in the European database on medical devices as a manufacturer, with 162 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa162

Most frequent device types declared: A100, A200, H100.

Devices declared under this manufacturer

Showing 12 of 162 declared devices.

Catalogue references include H100-323-STW-FCL, H100-425-STY-FCR, H100-427-STY-FCR, H100-428-FBR, H100-523-FBL, H100-525-STG-FCL.

European nomenclature codes declared: Y062499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED162
Country of registrationSweden

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

Device-level evidence

Devices with a numeric GTIN162
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. C LindheXtend AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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