EU → North America Device Access

ACIME FRAME

FR-MF-000016067 · France · LILLE

ACIME FRAME is registered in the European database on medical devices as a manufacturer, with 64 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa64

Most frequent device types declared: DUAD-BAR-AC, DUAD-STD-AC, FCIM-STD-NI, FIXA-PED-NI, FUSI-STD-AC.

Among these devices, 39 are declared active.

Devices declared under this manufacturer

Showing 12 of 64 declared devices.

Catalogue references include DUAD009, DUAD010, FCIM059, FIXA004, FUSI039, MANC035.

European nomenclature codes declared: V08020101, V08050101, V080603, V080502, V080202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryACIME FRAME (FR) · FDA 3030927791
Devices in EUDAMED64
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN64
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. ACIME FRAME is registered in the United States but was not found in the Canadian register.

Other manufacturers in France

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