Heraeus Medical GmbH
DE-MF-000008199 · Germany · Wehrheim
Heraeus Medical GmbH is registered in the European database on medical devices as a manufacturer, with 68 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 35 |
|---|---|
| Class IIb | 23 |
| Class IIa | 10 |
Most frequent device types declared: 1x40, 1x20, 2x40, 2x20, 1x60.
Among these devices, 66 are declared sterile, 58 implantable.
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 | Heraeus Medical GmbH (DE) · FDA 3006406161 |
| Devices in EUDAMED | 68 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 057633 0039 | supplemented | 2029-05-05 |
G70 057633 0036 | issued | 2029-03-13 |
G70 057633 0030 | issued | 2027-12-20 |