Heidelberg Engineering GmbH
DE-MF-000008127 · Germany · Heidelberg
Heidelberg Engineering GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: SPECTRALIS Platform DMR024, ANTERION Software V. 1.5, SPECTRALIS SP 1.19, ANTERION DMR007, SPECTRALIS Software V.7.4.
Among these devices, 1 are declared sterile, 4 active, 4 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 register | Registered with FDA |
|---|---|
| Matched entry | HEIDELBERG ENGINEERING GMBH (DE) · FDA 8043762 |
| Devices in EUDAMED | 6 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 106871 0008 | supplemented | 2030-12-17 |