Tecnoideal America
Country not established
- Devices
- 1
What Tecnoideal America makes
Tecnoideal America manufactures the Purema® H Hemoconcentrator, a device designed for blood filtration and concentration, sterilized using ethylene oxide.
The Purema® H Hemoconcentrator is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Purema® H Hemoconcentrator (EtO Sterilized) Ref K232171
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tecnoideal America have in the registry?
The registry currently lists 1 device for Tecnoideal America. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tecnoideal America's devices?
Among its 1 most recently registered device, Tecnoideal America has devices listed in FDA 510(k) (1 device).
What risk classes do Tecnoideal America's devices fall under?
Among its 1 most recently registered device, the classes recorded for Tecnoideal America's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tecnoideal America in the registry?
The most recently registered devices listed for Tecnoideal America include Purema® H Hemoconcentrator (EtO Sterilized).