Ensol Biosciences, Inc.
South KoreaFDA applicant, unverified
- Devices
- 1
What Ensol Biosciences, Inc. makes
Ensol Biosciences, Inc. manufactures the Ensol EnTM Specimen Collection and Transport System, a device designed for collecting and transporting biological specimens while maintaining sample integrity.
The company’s portfolio is regulated under FDA’s Class I device classification, with the relevant product authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ensol Biosciences, Inc. have in the registry?
The registry currently lists 1 device for Ensol Biosciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ensol Biosciences, Inc.'s devices?
Among its 1 most recently registered device, Ensol Biosciences, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Ensol Biosciences, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ensol Biosciences, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ensol Biosciences, Inc. in the registry?
The most recently registered devices listed for Ensol Biosciences, Inc. include Ensol EnTM Specimen Collection and Transport System.