PATH MEDICAL GmbH
DE-MF-000006935 · Germany · Germering
PATH MEDICAL GmbH is registered in the European database on medical devices as a manufacturer, with 131 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 131 |
|---|
Most frequent device types declared: 100120, A7i-101049, ABR-L, EC-02, ECC.
Among these devices, 66 are declared active, 16 with a measuring function.
Devices declared under this manufacturer
- ATA-L
- BC-01
- BC-RE2
- EC-05
- EP-TY
- ET-10
- ET-S01
- ET-S03
- Ear Cups (ECC)
- Insert Ear Phone Tip 14 mm
- Live speech microphone MIC-01
- NavPRO ONE
Showing 12 of 131 declared devices.
Catalogue references include 100029-100, 100064-100, 100188-US, 100360-NPO, 100779, 100890-30.
European nomenclature codes declared: Z12140380,Z12149001, Z12140380,Z12149001,Z12149005, Z12140380, Z121401, Z12140380,Z12140480,Z12149080, Z12140302.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 131 |
| 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 | 131 |
|---|---|
| Found in the U.S. device database | 125 |
| Share | 95.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PATH MEDICAL GMBH |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| First licensed | 2013-03-14 |
Licence types: System (3), Device Group Family (2).
Licensed under: SENTI, SENTIERO, QSCREEN, SENTIERO, NANOTYMP.
North American profile: Canada only. PATH MEDICAL GmbH holds a Canadian licence but was not found in the U.S. register.