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.
Devices declared under this manufacturer
- Calbreak
- Guard I
- Helix
- Idealcath
- Mercury
- Migress
- NC Osier™
- Rayline
- SWL-Origin
- SWL-Pathfinder
- SWL-Pioneer
- SWL-Transmooth
Showing 12 of 1 982 declared devices.
Catalogue references include BDC842891, CDC843817, GC824644, HGW826369, MDS831859, PAGW827517.
European nomenclature codes declared: C010402020101, C010401020101, C0104010202, Z12109001, C0104010101, C0504.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 982 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 1 982 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. SWL Medizin GmbH was not found in either the U.S. or the Canadian register.
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 |