Honeywell Healthcare Solutions GmbH
DE-MF-000004924 · Germany · Wismar
Honeywell Healthcare Solutions GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 9 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: Pulse Oximetry Monitor.
Among these devices, 1 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- OOM101
- OOM101 MAX
- OOM101 VIA
- OOM101-M Mal
- OOM109
- OOM201
- OOM201 CAN
- OxiPen (ohne Sensor)
Catalogue references include 01-00-0013, AA844-210, E01-00-0014, E1001707, E1002622, E1002629.
European nomenclature codes declared: R9080, Z1203020408.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| 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 | 10 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HONEYWELL HEALTHCARE SOLUTIONS GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2005-01-11 |
Licence types: Device Family (4).
Licensed under: MULTI-COMPATIBLE SP02 SENSORS, FLOW SENSORS, SPO2 ADAPTOR CABLE, GALVANIC OXYGEN SENSORS.
North American profile: Canada only. Honeywell Healthcare Solutions GmbH holds a Canadian licence but was not found in the U.S. register.