Data / Medical devices / Ireland / Novaerus Ltd
Novaerus Ltd: FDA-registered device maker in Blackrock Dublin(County), Ireland, 1 510(k) clearance
Novaerus Ltd is registered with the FDA (registration 3010238358) in Blackrock Dublin(County), Ireland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 28, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010238358
- Address
- Oyster Point Temple Road, Blackrock Dublin(County), Ireland, A94 R2N3
- Owner or operator
- Novaerus US Inc. (10082124)
- Roles
- Manufacturer
- First device listed
- June 17, 2021
- Registered through
- 2026
- Brand names listed
- Novaerus Defend 1050, Novaerus Defend 400, Novaerus NV1050, Novaerus NV400, Novaerus Pro XL, WellAir Defend 1050, WellAir Defend 400, WellAir NV1050 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Air, Medical Recirculating | FRF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 28, 2020 | K200321 | Novaerus NV1050 | FRF | Substantially Equivalent | Novaerus Us, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 28, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.