Heyer Medical AG
DE-MF-000014330 · Germany · Schwerin
Heyer Medical AG is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 15 |
|---|---|
| Class IIb | 6 |
| other | 4 |
Most frequent device types declared: Many, Multiple Models, Grundgerät, Grundgerät mit Oxygen cylinder set Italienisch, Grundgerät Englisch.
Among these devices, 21 are declared active, 6 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 | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 25 |
| Country of registration | Germany |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 108227 0002 | issued | 2028-03-01 |
EU-TDA-FI-92091-800168-2026 | issued | 2031-07-14 |
EU-QMS-FI-88700-800168-2026 | issued | 2031-07-14 |