EU → US Device Access

Aesculap AG

DE-MF-000005504 · Germany · Tuttlingen

Aesculap AG is registered in the European database on medical devices as a manufacturer, with 14 519 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa11 984
Class IIb2 528
Class I7

Among these devices, 2 684 are declared sterile, 2 053 implantable, 5 077 reusable, 524 active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAESCULAP AG (DE) · FDA 9610612
Devices in EUDAMED14 519
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
G12 010066 0441supplemented2026-06-30
G11 010066 0437reissued2030-07-09
G10 010066 0438reissued2030-07-09
20003GB450260622reissued2031-06-22

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