EU → North America Device Access

ALN

FR-MF-000000841 · France · Bormes les Mimosas

ALN is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I19

Among these devices, 19 are declared sterile, 16 implantable.

Devices declared under this manufacturer

Showing 12 of 19 declared devices.

Catalogue references include FB.010500, FB.HOOK, FBH.OATF19, FF.HOOK, FF.OATF19, FJ.120096.

European nomenclature codes declared: C01050101, C019005.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
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 GTIN19
Found in the U.S. device database9
Share47.4 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. ALN was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
1000316916amended2029-11-13
1000316897amended2030-10-26
1000316896amended2029-11-13
1000316890amended2029-11-13

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