EU → North America Device Access

Ab medica sas

FR-MF-000000154 · France · MERY SUR CHER

Ab medica sas is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Fork, Pointer Cannula, Pointer Tip.

Among these devices, 6 are declared reusable.

Devices declared under this manufacturer

Catalogue references include C9-TL-T20, F1-B1-13, P1-D6-K14-M4L280-C, P1-D6-K14-M4L280-T, P1-D6-K14-M4L331-C, P1-D6-K14-M4L331-T.

European nomenclature codes declared: L091001, L091099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAB MEDICA SAS (FR) · FDA 3011221476
Devices in EUDAMED8
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN8
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryAB MEDICA SAS

What it holds in Canada

Licences on record4
Currently active0
Class 2 devices4
First licensed2024-05-15

Licence types: System (3), Device Family (1).

Licensed under: TROCAR INSTRUMENT, BIPOLAR LAPAROSCOPIC FORCEPS, MONOPOLAR INSTRUMENTS AND HAND INSTRUMENTS, RIGID ENDOSCOPES AND ACCESSORIES.

North American profile: Both markets. Ab medica sas is registered in both the United States and Canada.

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