EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 14 519 declared devices.

Catalogue references include BC803R, BD220R, BV349R, FK110R, NS349R, NS665.

European nomenclature codes declared: L091199, Z12100980, S010401, P09070302, P09070399, L010403.

United States market access

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

Device-level evidence

Devices with a numeric GTIN14 519
Found in the U.S. device database10 564
Share72.8 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryAESCULAP AG

What it holds in Canada

Licences on record30
Currently active0
Class 2 devices24
Class 3 devices2
Class 4 devices4
First licensed1999-06-16

Licence types: Device Family (15), System (10), Single Device (3), Device Group Family (1).

Licensed under: APPLYING FORCEPS FOR AESCULAP YASARGIL ANEURYS, LAPAROSCOPES, VENTRICULOSCOPES, TROCARS, SCALP CLIPS, ARTHROSCOPES.

North American profile: Both markets. Aesculap AG is registered in both the United States and Canada.

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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