Contract manufacturerTWO ONE TWO NEW YORK, INC. (Edgewood, NY)New YorkGeneral and plastic surgeryRadiologyGeneral hospitalClass INot classified
TWO ONE TWO NEW YORK, INC.
Contract manufacturer ยท Edgewood, NY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3013269506 (openFDA record; or search FDA's registration database)
- FEI number
- 3013269506
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Two One Two New York, Inc. (FDA owner/operator no. 10077084)
- Registered address
- 60 Heartland Blvd, Edgewood, NY 11717
- Contract listings
- 5 device listings, 5 product codes, first listed Aug 11, 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 |
|---|---|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | Class I | General and plastic surgery | Contract manufacturing | Aug 21, 2020 |
| FYF | Cap, Surgical | Class I | General and plastic surgery | Contract manufacturing | Aug 21, 2020 |
| IWO | Apron, Protective | Class I | Radiology | Contract manufacturing | Aug 21, 2020 |
| OEA | Non-Surgical Gown | Class I | General and plastic surgery | Contract manufacturing | Aug 11, 2020 |
| 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 17, 2020 |