EU → North America Device Access

QUIBIM S.L.

ES-MF-000000668 · Spain · Valencia

QUIBIM S.L. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa3
Class IIb4

Most frequent device types declared: BR, LV, PR, VW.

Among these devices, 7 are declared active, 7 with a measuring function.

Devices declared under this manufacturer

Catalogue references include 1.0, 1.1, 2.3, 2.4, 2.5, 3.0.

European nomenclature codes declared: Z11069092.

United States market access

FDA establishment registerRegistered with FDA
Matched entryQUIBIM S.L. (ES) · FDA 3025343020
Devices in EUDAMED7
Country of registrationSpain

Device-level evidence

Devices with a numeric GTIN7
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryQUIBIM S.L.

What it holds in Canada

Licences on record1
Currently active0
Class 3 devices1
First licensed2026-06-09

Licence types: Single Device (1).

Licensed under: QP-PROSTATE.

North American profile: Both markets. QUIBIM S.L. is registered in both the United States and Canada.

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