Robert Helwig GmbH
DE-MF-000012987 · Germany · Königs Wusterhausen
Robert Helwig GmbH is registered in the European database on medical devices as a manufacturer, with 509 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 509 |
|---|
Most frequent device types declared: Injektionskanülen unsteril zum Einmalgebrauch, Saugkanülen unsteril zum Einmalgebrauch.
Devices declared under this manufacturer
- Injektionskanüle 0,60 x 30 mm, Luer Lock
- Injektionskanüle 0,60 x 80 mm, Luer Lock
- Injektionskanüle 0,70 x 42 mm, Luer Lock
- Injektionskanüle 0,70 x 60 mm, Luer Lock
- Injektionskanüle 0,80 x 100 mm, Luer Lock
- Injektionskanüle 1,20 x 50 mm, Luer Lock
- Injektionskanüle 1,80 x 20 mm, Luer Lock
- Injektionskanüle 2,00 x 28 mm, Luer Lock
- Liposuctions-Kanüle 4,00 x 300 mm, mit Tip-Trol Luer, vorn verschlosse
- OP-Sauger 5: 3,80 x 135 mm, gebogen, Griff mit Tip-Trol, 1 Griffmulde,
- Wullstein-Sauger 1,80 x 75 mm, Luer, gebogen, stumpf, Olive 8 mm
- Wullstein-Sauger 3,50 x 75 mm, Luer Lock, stumpf, gebogen
Showing 12 of 509 declared devices.
Catalogue references include 315180075, 32060030, 32060080, 32070042, 32120050, 400100200.
European nomenclature codes declared: A01010199, A019009.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 509 |
| 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 | 509 |
|---|---|
| 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. Robert Helwig GmbH was not found in either the U.S. or the Canadian register.