EU → North America Device Access

Bentley InnoMed GmbH

DE-MF-000005507 · Germany · Hechingen

Bentley InnoMed GmbH is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb66

Most frequent device types declared: BeGraft Peripheral Plus Stent Graft System, BeGraft Peripheral Stent Graft System.

Among these devices, 66 are declared sterile, 66 implantable.

Devices declared under this manufacturer

Showing 12 of 66 declared devices.

Catalogue references include BGP+2806_2, BGP+3710_2, BGP2708_1, BGP2806_2, BGP3707_2, BGP3806_2.

European nomenclature codes declared: P0704020299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBENTLEY INNOMED GMBH (DE) · FDA 3009128730
Devices in EUDAMED66
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN66
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryBENTLEY INNOMED GMBH

What it holds in Canada

Licences on record1
Currently active0
Class 4 devices1
First licensed2026-07-14

Licence types: Device Family (1).

Licensed under: BEFLARED FEVAR STENT GRAFT SYSTEM.

North American profile: Both markets. Bentley InnoMed GmbH is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
G15 122931 0009issued2028-04-17
7490GB448241220issued2028-04-17

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