EU → North America Device Access

asap endoscopic products GmbH

DE-MF-000005511 · Germany · Umkirch

asap endoscopic products GmbH is registered in the European database on medical devices as a manufacturer, with 295 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa295

Most frequent device types declared: Rigid Endoscopes - ENT, Rigid Endoscopes - Esophagoscopy, Rigid Endoscopes -Pneumology, TD12 - Rigid Endoscopes - Spinal Surgery, TV-Adapter.

Among these devices, 206 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 295 declared devices.

Catalogue references include 10-0053-00, 10-0054-00, 10-0065-TM, 10-0086-RUSF, 10-0250-00, 10-0488-00RD.

European nomenclature codes declared: Z12029099, L0317.

United States market access

FDA establishment registerRegistered with FDA
Matched entryasap endoscopic products GmbH (DE) · FDA 3008494403
Devices in EUDAMED295
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN295
Found in the U.S. device database1
Share0.3 %

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. asap endoscopic products GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →