Entomed AB
SwedenFDA applicant, unverified
- Devices
- 1
What Entomed AB makes
Entomed AB manufactures audiometers, including screening and diagnostic models such as the SA201, SA202, SA203, and SA204. These devices are designed for hearing assessments, supporting clinical evaluations of auditory function in medical settings.
The company’s audiometers are classified as Class II devices under FDA regulations and are listed via 510(k) clearance. The portfolio is regulated in the United States, where Entomed AB is based.
Catalogue
Entomed Screening Audiometer, Model SA201, SA202, Entomed Diagnostic Audiometer Model SA203, SA204 Ref K092111
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Entomed AB have in the registry?
The registry currently lists 1 device for Entomed AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entomed AB's devices?
Among its 1 most recently registered device, Entomed AB has devices listed in FDA 510(k) (1 device).
What risk classes do Entomed AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Entomed AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entomed AB in the registry?
The most recently registered devices listed for Entomed AB include ENTOMED SCREENING AUDIOMETER, MODEL SA201, SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203, SA204.