Udo Heisig GmbH The Disposables Company
DE-MF-000009334 · Germany · Putzbrunn
Udo Heisig GmbH The Disposables Company is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 108 |
|---|
Among these devices, 99 are declared sterile.
Devices declared under this manufacturer
- FLEXASOFT® Lichtkabel-Bezug
- FLEXASOFT® Ultraschall-Abdeckung
- FLEXASOFT® Ultraschall-Bezug
- FLEXASOFT® Ultraschall-Bezug für Gel
- OPTANORM® Lichtkabel-Bezug
- STERINORM® Bodennaht-Beutel
- STERINORM® Flachboden-Beutel
- STERINORM® Rund-Haube
- STERINORM® Schlauchbezug für C-Spange
- STERINORM® Spangenbezug C-SET
- STERINORM® Viereck-Haube
- UNIFLEX® Faltenschlauch für TUR
Showing 12 of 108 declared devices.
Catalogue references include 30085, 30094, 31301, 31903, 32017U, 35408.
European nomenclature codes declared: T030101, T030199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 108 |
| 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 | 108 |
|---|---|
| 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. Udo Heisig GmbH The Disposables Company was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1754014-1 | issued | 2027-06-22 |