HCE GmbH
DE-MF-000028621 · Germany · Hamburg
HCE GmbH is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 15 |
|---|
Devices declared under this manufacturer
- ActiRhino Maux de gorge goût cerise
- Multinorm Halspastillen Kirsch-Geschmack
- Multinorm Halspastillen Zitrone-Salbei-Geschmack
- Multinorm Sore Throat Lozenges Cherry Flavour
- Multinorm Sore Throat Lozenges Lemon Sage Flavour
- OROFAR Manuka
- Optisana ISLÄNDISCH MOOS HALSPASTILLEN
- Optisana Icelandic Moss Throat Pastilles
- Optisana PASTILLES À LA MOUSSE D'ISLANDE
- Sanactiv Halsschmerz Lutschtabletten Kirsch-Geschmack
- SilaVit Isländisch Moos Halspastillen Johannisbeer-Minz-Geschmack
- SilaVit Reizhusten Lutschpastillen mit Manuka-Honig Kirschgeschmack
Showing 12 of 15 declared devices.
Catalogue references include MP-09AV1, MP-09AV2, MP-09AV5, MP-09BV2a, MP-09BV3.
European nomenclature codes declared: V9017.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 15 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. HCE GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
20393GB448250731 | issued | 2030-02-18 |