SWL Medizin GmbH
DE-MF-000008000 · Germany · Darmstadt
SWL Medizin GmbH is registered in the European database on medical devices as a manufacturer, with 1 982 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 1 515 |
|---|---|
| Class IIa | 467 |
Most frequent device types declared: MDS 10, MDS 14, MDS 3D, PGW-14300S-007.
Among these devices, 1 982 are declared sterile, 242 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 | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 982 |
| 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 |
|---|---|---|
MDR.2292-2026/0008 | issued | 2031-03-11 |
MDR.2292-2026/0007 | issued | 2031-03-11 |
2QMS-MDR-0065/06/2026 | issued | 2029-06-04 |
1TD-MDR-0065/06/2026/02 | issued | 2029-06-04 |
1TD-MDR-0065/06/2026/01 | issued | 2029-06-04 |
1QMS-MDR-0065/06/2026 | issued | 2031-06-04 |