Data / Medical devices / Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier (NUP): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Cream, Nasal, Topical, Mechanical Allergen Particle Barrier (product code NUP, Class 2, 21 CFR 880.5045). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on June 24, 2022, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- NUP
- Device class
- 2
- Regulation
- 880.5045
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Isle of Man | 1 |
| United Kingdom | 1 |
| Canada | 1 |
Makers of Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Nasaleze Group | Douglas, Isle of Man | Contract manufacturer, Exporter to the US, Manufacturer | 3 | March 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Haymax Limited | Conwy Gwynedd, United Kingdom | Specification developer | 1 | May 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Hudson Scientific LLC | Hudson, MI, United States | Specification developer | 1 | June 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Kenvue Brands LLC | Summit, NJ, United States | Specification developer | 1 | December 31, 2013 | 0 | 0 | 0 | api.fda.gov |
| Pillar5 Pharma Inc. | Arnprior Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 24, 2022. 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.