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: ANTERION DMR007, ANTERION Software V. 1.5, SPECTRALIS Platform DMR024, SPECTRALIS SP 1.19, SPECTRALIS Software V.7.4.
Among these devices, 1 are declared sterile, 4 active, 4 with a measuring function.
Devices declared under this manufacturer
- ANTERION
- ANTERION Software
- SPECTRALIS
- SPECTRALIS Platform
- TomoCaps
Catalogue references include 18829, 4001670, 4002968, 600300, 88033, 88036.
European nomenclature codes declared: Z12120121, Z12120192, Z12120185.
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 |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 33.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HEIDELBERG ENGINEERING GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2006-04-05 |
Licence types: System (2), Device Family (2).
Licensed under: HRT3 LASER SCANNING OPHTHALMOSCOPE, SPECTRALIS, SPECTRALIS SOFTWARE, ANTERION.
North American profile: Both markets. Heidelberg Engineering GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 106871 0008 | supplemented | 2030-12-17 |