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Spiegelberg GmbH & Co. KG

DE-MF-000000008 · Germany · Hamburg

Spiegelberg GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class I33
Class IIa5

Most frequent device types declared: NKT.1.ST, ICP.1.ST, ICP.3.ST, ELD33.010.02, EVD30.030.01.

Among these devices, 36 are declared sterile, 2 active, 2 with a measuring function.

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 entrySPIEGELBERG GmbH & Co. KG (DE) · FDA 3002108226
Devices in EUDAMED38
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
1000265951issued2030-10-22
1000265927issued2029-03-20
1000216002issued2030-03-12
1000210544issued2029-03-20

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