EU → North America Device Access

AMS OOD

BG-MF-000044546 · Bulgaria · Kardzhali

AMS OOD 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 IIa19

Most frequent device types declared: 4М-014, Isospace 4E-014, Isospace ICB-P-011, Isospace M05, Isospace M06.

Devices declared under this manufacturer

Showing 12 of 19 declared devices.

Catalogue references include 4M-014, 4Е-014, Isospace ICB-P-011, Isospace K09, K015, M05.

European nomenclature codes declared: V9099, V0899, Z12099003, V08050199, V080602, V08060102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
Country of registrationBulgaria

⚠️ 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 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: Neither register. AMS OOD was not found in either the U.S. or the Canadian register.

Other manufacturers in Bulgaria

All Bulgaria manufacturers →