Helmut Schwarz GmbH
DE-MF-000015181 · Germany · Isny
Helmut Schwarz GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: Mehrweg-Medikamentenbecher, 25 ml, Schnabelbecher standard, melinip Einweg-Medikamentenbecher, 25 ml, melinip Schnabelbecher apart.
Devices declared under this manufacturer
- melinip Schnabelbecher ECO, Breideckel, 12 mm Auslass
- melinip Schnabelbecher ECO, Trinkdeckel, 4 mm Auslass
- melinip Schnabelbecher apart, Deckel
- melinip Schnabelbecher apart, Unterteil, 250 ml
- melinip Schnabelbecher standard, Unterteil
- melipul Einweg-Medikamentenbecher, 25 ml
- melipul Mehrweg-Medikamentenbecher, 25 ml
Catalogue references include 01031100, 010332, 010342, 0104011, 01043, 013050.
European nomenclature codes declared: Y150999, Y150915.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| 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 | 7 |
|---|---|
| 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. Helmut Schwarz GmbH was not found in either the U.S. or the Canadian register.