Contract manufacturerGU USA LLC (New York, NY)New YorkOphthalmicClass I
GU USA LLC
Contract manufacturer · New York, NY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3031743580 (openFDA record; or search FDA's registration database)
- FEI number
- 3031743580
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- GU USA LLC (FDA owner/operator no. 10091166)
- Registered address
- 38 Gansevoort St, New York, NY 10014
- Contract listings
- 1 device listings, 1 product codes, first listed Jul 15, 2024
- 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 |
|---|---|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Class I | Ophthalmic | Contract manufacturing | Jul 15, 2024 |