Contract manufacturerSwiss-American CDMO,LLC (Carrollton, TX)TexasGastroenterology and urologyGeneral and plastic surgeryGeneral hospitalObstetrics and gynecologyClass IUnclassifiedClass II
Swiss-American CDMO,LLC
Contract manufacturer · Carrollton, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1649690 (openFDA record; or search FDA's registration database)
- FEI number
- 3001451826
- Registered for
- FDA registration year 2027
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Swiss-American CDMO, LLC (FDA owner/operator no. 9020887)
- Registered address
- 2055 Luna Rd Ste 126, Carrollton, TX 75006
- Contract listings
- 17 device listings, 8 product codes, first listed Oct 29, 2008
- 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 |
|---|---|---|---|---|---|
| FON | Bag, Drainage, With Adhesive, Ostomy | Class I | Gastroenterology and urology | Contract manufacturing | Nov 6, 2012 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract manufacturing | Oct 29, 2008 |
| KMF | Bandage, Liquid | Class I | General hospital | Contract manufacturing | Feb 26, 2010 |
| KOX | Solvent, Adhesive Tape | Class I | General and plastic surgery | Contract manufacturing | Nov 6, 2012 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class I | General and plastic surgery | Contract manufacturing | Apr 6, 2009 |
| NEC | Bandage, Liquid, Skin Protectant | Class I | General hospital | Contract manufacturing | Nov 6, 2012 |
| NUC | Lubricant, Personal | Class II | Obstetrics and gynecology | Contract manufacturing | Jul 5, 2023 |
| PEB | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | Class II | Obstetrics and gynecology | Contract manufacturing | Oct 9, 2026 |