Novaerus Ltd

FDA Device Registration & Listing · Blackrock Dublin, IE · Registration 3010238358

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010238358
FEI Number
3010238358
Entity Name
Novaerus Ltd
City/State/Country
Blackrock Dublin, IE
Establishment Address
Oyster Point, Temple Road, Blackrock Dublin A94 R2N3, IE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Novaerus US Inc. (Owner Number: 10082124)
Owner / Operator Contact Address
3540 Toringdon Way, Suite 200, Charlotte, NC 28277, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200321
PMA Number
N/A

All Registered Proprietary Names

Novaerus Defend 400 Novaerus Defend 1050 WellAir Pro XL Novaerus Pro XL WellAir NV400 WellAir NV1050 Novaerus NV400 WellAir Defend 1050 Novaerus NV1050 WellAir Defend 400

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRF Cleaner, Air, Medical Recirculating General Hospital Class 2 880.5045 2021-06-17

Official Correspondent

Lisa Lawlor

US Agent Details

Lisa Lawlor Business: Novaerus US Inc Email: llawlor@wellair.ie Phone: (866) 5081118

Related Public Records

Same Entity

Novaerus US Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3019543795 NOVAERUS US INC. Charlotte, NC, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010238358. Last updated year: 2026. Please use registration number 3010238358 when referencing this establishment in official correspondence.
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