Tecme S.A.
Country not established
- Devices
- 2
What Tecme S.A. makes
Tecme S.A. manufactures respiratory monitoring devices, including the NEUMOVENT GRAPHNET and its variant, the NEUMOVENT GRAPHNET Model 3179L1V. These products are designed for capturing and analyzing ventilatory data, such as airflow and volume measurements, to support clinical assessment and patient management in respiratory care settings.
The company’s portfolio is regulated under Class II medical devices in the United States, with devices listed via the FDA’s 510(k) pathway. Tecme S.A. is based in the US, adhering to applicable regulatory requirements for these specialized respiratory monitoring systems.
Catalogue
Neumovent Graphnet Ref K111595
Regimes: 510(k) Registry: 510(k)Neumovent Graphnet Model 3179L1V Ref K101401
Regimes: CE MDD 510(k) Registry: EUDAMED510(k)GUDID
Frequently asked questions
How many devices does Tecme S.A. have in the registry?
The registry currently lists 2 devices for Tecme S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tecme S.A.'s devices?
Among its 2 most recently registered devices, Tecme S.A. has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Tecme S.A.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Tecme S.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tecme S.A. in the registry?
The most recently registered devices listed for Tecme S.A. include NEUMOVENT GRAPHNET and NEUMOVENT GRAPHNET MODEL 3179L1V.