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 IIa | 10 |
| Class IIb | 23 |
Most frequent device types declared: 1x20, 1x40, 1x60, 2x10, 2x20.
Among these devices, 66 are declared sterile, 58 implantable.
Devices declared under this manufacturer
- COPAL G+C
- COPAL knee moulds
- OSTEOPAL V
- OSTEOPAL plus
- PALACOS LV
- PALACOS LV+G
- PALACOS MV
- PALACOS MV+G
- PALACOS R
- PALACOS R+G
- PALAMIX
- PALAMIX nozzle slim
Showing 12 of 68 declared devices.
Catalogue references include 66017772_Legacy, 66022662_Legacy, 66031896_Legacy, 66036748, 66041214_Legacy, 66055104_Legacy.
European nomenclature codes declared: P099001, P099002.
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 |
Device-level evidence
| Devices with a numeric GTIN | 68 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 13.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HERAEUS MEDICAL GMBH |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 8 |
| First licensed | 2000-05-29 |
Licence types: Device Family (4), Single Device (3), Device Group (2).
Licensed under: PALACOS BONE CEMENT, PALACOS BONE CEMENT WITH GENTAMICIN, OSTEOPAL V RADIOPAQUE BONE CEMENT FOR VERTEBRO, COPAL G+C, PALACOS R+G PRO, COPAL G+V.
North American profile: Both markets. Heraeus Medical GmbH is registered in both the United States and Canada.
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 |