HILOTHERM GmbH
DE-MF-000006176 · Germany · Eisenharz
HILOTHERM GmbH is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 80 |
|---|
Most frequent device types declared: Hilotherapy Device HT02, Hilotherapy Device HTP1 Pro.
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- Anschlussschlauch 2m, mit Knickschutz
- Brustmanschette Hilobreast MM
- Flächenmanschette klein EM
- Fußmanschette ChemoCare 3rd Gen. MM
- Fußmanschette MM
- Gesichtsmanschette unten mit Steg EM
- HILOTHERM HTP1 Professionell inkl. Zubehör
- Handmanschette EM
- Hilofix 25 mm x 65 cm
- Hilotherm ChemoCare-CIA 115V inkl. Zubehör
- Rundmanschette EM
- Small Surface Cuff multi-use
Showing 12 of 80 declared devices.
Catalogue references include 00102010, 15000005, 16000010, 16000027, 16000318, 20111510.
European nomenclature codes declared: M9001.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HILOTHERM GMBH (DE) · FDA 3011853381 |
| Devices in EUDAMED | 80 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 80 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 3.8 % |
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: United States only. HILOTHERM GmbH is registered in the United States but was not found in the Canadian register.