TNI medical AG
DE-MF-000006128 · Germany · Würzburg
TNI medical AG is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 16 |
|---|
Most frequent device types declared: 40610001, 40610021, 40610250, 40630001, 40630004.
Among these devices, 16 are declared active.
Devices declared under this manufacturer
- Applicator Clinic Large
- Applicator Clinic Small
- Applicator Clinic Small Plus
- Applicator Clinic Standard
- Applicator Homecare Large
- Applicator Homecare Small
- Applicator Homecare Small Plus
- Applicator Homecare Standa
- Applikator Clinic Medium
- Applikator Homecare Medium
- Masimo softFlow
- TNI softFlow 50 clinic
Showing 12 of 16 declared devices.
Catalogue references include 40610001, 40610250, 40630001, 40630004, 40630005, 40630013.
European nomenclature codes declared: R060202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TNI MEDICAL AG (DE) · FDA 3010063021 |
| Devices in EUDAMED | 16 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 37.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TNI MEDICAL AG |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2023-01-11 |
Licence types: System (1).
Licensed under: MASIMO SOFTFLOW.
North American profile: Both markets. TNI medical AG is registered in both the United States and Canada.