Contract manufacturerBREATHH INC (San Diego, CA)CaliforniaMicrobiologyGeneral hospitalNot classified
BREATHH INC
Contract manufacturer ยท San Diego, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3017171515 (openFDA record; or search FDA's registration database)
- FEI number
- 3017171515
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Breathh Inc (FDA owner/operator no. 10076872)
- Registered address
- 2295 Paseo De Las Americas, Suite 19, San Diego, CA 92154
- Contract listings
- 2 device listings, 2 product codes, first listed Aug 3, 2020
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| QKP | Coronavirus Antigen Detection Test System. | Not classified | Microbiology | Contract manufacturing | Jan 24, 2024 |
| QKR | Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Not classified | General hospital | Contract manufacturing | Aug 3, 2020 |