Data / Medical devices / Isle of Man / Nasaleze Group
Nasaleze Group: FDA-registered device maker in Douglas, Isle of Man, 3 510(k) clearances
Nasaleze Group is registered with the FDA (registration 3011788145) in Douglas, Isle of Man. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011788145
- Address
- Unit 3 Woodside House Ballafletcher Business Park, Douglas, Isle of Man, IM44QE
- Owner or operator
- Nasaleze International Ltd (10049830)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 7, 2015
- Registered through
- 2026
- Brand names listed
- AllerBlock Adult, AllerBlock Junior, AllerBlock Travel, Alzair
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | NUP | 2 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 26, 2021 | K201734 | AllerBlock Junior | NUP | Substantially Equivalent | Nasaleze International, Ltd. | accessdata.fda.gov |
| June 14, 2017 | K170848 | Alzair Allergy Blocker | NUP | Substantially Equivalent | Nasaleze International, Ltd. | accessdata.fda.gov |
| December 31, 2013 | K132520 | NASAL EASE ALLERGY BLOCKER | NUP | Substantially Equivalent | Hi-Tech Pharmacal, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 26, 2021. 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.