Timpel, Inc.
BrazilFDA applicant, unverified
- Devices
- 1
What Timpel, Inc. makes
Timpel, Inc. manufactures the Enlight 1810, a medical imaging device designed for specific diagnostic applications in radiology, likely involving fluoroscopy or X-ray imaging.
The company’s portfolio is regulated under FDA’s Class II device classification, with the Enlight 1810 authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) registry. Timpel, Inc. is based in the United States.
Catalogue
Enlight 1810 Ref DEN170072
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Timpel, Inc. have in the registry?
The registry currently lists 1 device for Timpel, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Timpel, Inc.'s devices?
Among its 1 most recently registered device, Timpel, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Timpel, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Timpel, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Timpel, Inc. in the registry?
The most recently registered devices listed for Timpel, Inc. include Enlight 1810.