EU → North America Device Access

Parabel s.r.o.

CZ-MF-000002892 · Czechia · Lukov

Parabel s.r.o. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: LokoBasic, LokoStation 55.

Among these devices, 4 are declared active.

Devices declared under this manufacturer

Catalogue references include LBS103, LBS104, P100001, P100002, P100392X, P100393X.

European nomenclature codes declared: Y050202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPARABEL S.R.O. (CZ) · FDA 3007710870
Devices in EUDAMED6
Country of registrationCzechia

Device-level evidence

Devices with a numeric GTIN6
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: United States only. Parabel s.r.o. is registered in the United States but was not found in the Canadian register.

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