Micromed, Inc.
United StatesFDA applicant, unverified
Part of Micromed SRL
Micromed, Inc. is a medical device manufacturer, with 14 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 14
Registry facts
- Registries
- FDA GUDID 11
- EUDAMED 4
- FDA 510(k) 3
- Device classes
- FDA Class II 14
- Sites and related companies
What Micromed, Inc. makes
Micromed, Inc. manufactures electroencephalographic (EEG) monitoring systems, including standalone electroencephalographs and modules for patient monitoring. Their portfolio also includes ophthalmic flash generators, polysomnographs for sleep studies, and bioelectrical signal analysis software. Additionally, they produce somatosensory electrical stimulation systems for therapeutic applications.
The company’s devices are classified as Class II under FDA regulations and are authorised via 510(k) clearances and De Novo pathways. Their products are listed in the FDA’s regulatory databases, including the 510(k) and UDI registries.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Micromed, Inc. have in the registry?
The registry currently lists 14 devices for Micromed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micromed, Inc.'s devices?
Among its 14 most recently registered devices, Micromed, Inc. has devices listed in EUDAMED (4 devices), FDA 510(k) (3 devices) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Micromed, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Micromed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Micromed, Inc. in the registry?
The most recently registered devices listed for Micromed, Inc. include micromed BRAIN SPY PLUS, micromed SD LTM 64 EXPRESS, Micromed SD LTM STIM and micromed SystemPlus EVOLUTION.