Aseptico, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000014012 FEI 3017604
Aseptico, Inc. is a medical device manufacturer based in the United States, with 133 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class IIa and I) as of 14 Nov 2026.
- Devices
- 133
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 109
- EUDAMED 39
- FDA 510(k) 18
- Device classes
- FDA Class I 93
- EU Class IIa 28
- EU Class I 9
- FDA Class II 2
- FDA Unclassified 1
- Top EMDN categories
- Sites and related companies
- Advena Limited authorised representative
- Identifiers
- EUDAMED SRN US-MF-000014012
- FDA FEI 3017604
- DUNS 016853348
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Advena LimitedMT
What Aseptico, Inc. makes
Aseptico, Inc. manufactures dental surgical power tools, including electric motorized handpieces and sets, as well as ultrasonic scaling systems for dental debridement. Their portfolio also includes endodontic obturation systems, orthodontic wires, and dental delivery systems. Mobile examination/treatment room lights are part of their product line, alongside specialized dental power tool systems powered by line current.
The company’s devices are classified under FDA categories Class I, Class II, Class IIa, and Class U, with registrations in the EU’s eudamed database and FDA submissions via 510(k) and UDI pathways. Aseptico, Inc. is headquartered in the United States.
Catalogue
Search and filter all 133 devicesShowing 1-50 of 133
Company details
- EUDAMED SRN
- US-MF-000014012
- FDA FEI number
- 3017604
- DUNS number
- 016853348
- EUDAMED status
- Active
- EUDAMED registered name
- Aseptico, Inc.
- Registered address
- 8333 216th St SE, 98072, Woodinville, United States
- Phone
- 14254873157
- PRRC contact
- Grant Ramaley
Frequently asked questions
How many devices does ASEPTICO, INC. have in the registry?
The registry currently lists 133 devices for ASEPTICO, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ASEPTICO, INC.'s devices?
Among its 50 most recently registered devices, ASEPTICO, INC. has devices listed in EUDAMED (7 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ASEPTICO, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ASEPTICO, INC.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from ASEPTICO, INC. in the registry?
The most recently registered devices listed for ASEPTICO, INC. include Dentsply Sirona, Dentsply Sirona AA-65BASE-DS, Aseptico AEU-350S-W and Aseptico AE-24DIS.