EU → North America Device Access

Pul Concept

FR-MF-000002209 · France · NOYERS SUR CHER

Pul Concept is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include JAPS, PHAD, PHAG, PHSD, PHSG, SP1T.

European nomenclature codes declared: Q010499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
Country of registrationFrance

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

Device-level evidence

Devices with a numeric GTIN13
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryPUL CONCEPT

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2025-09-26

Licence types: Device Group Family (1).

Licensed under: PUL KITS.

North American profile: Canada only. Pul Concept holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in France

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