hestomed GmbH
DE-MF-000006850 · Germany · Chemnitz
hestomed GmbH is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 41 |
|---|---|
| Class IIb | 9 |
Among these devices, 23 are declared active.
Devices declared under this manufacturer
- Druckminderer redox. digital AIR
- Druckminderer redox. varius O2
- Kompaktflowmeter redox. click 0-15 L
- Kompaktflowmeter redox. click 0-15 L; G1/4\
- Kompaktflowmeter redox. click 0-30 L
- Rettungsdecke gold/silber
- Wandentnahmestelle redox plug-in AIR, Unterputz, Anschluss links
- Wandentnahmestelle redox plug-in AIR, Unterputz, Anschluss oben
- Wandentnahmestelle redox plug-in O2, Unterputz, Anschluss oben
- redconnect. Fahrtragenadapter CPS
- redconnect. Fahrtragenadapter Power X
- redconnect. Fahrtragenadapter PowerPro XT/2
Showing 12 of 50 declared devices.
Catalogue references include 210102900, 210103605, RC1T-03-DE-15, RC1T-08-DE-30, RC1U-08-G1-15, RCR2T-08-15.
European nomenclature codes declared: Z120309, A030104, T0399, V08050199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 50 |
| 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 | 50 |
|---|---|
| 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. hestomed GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 064409 0012 | issued | 2028-12-21 |