FDA Registration
Active
🇺🇸 United States
Swiss-American CDMO,LLC
Reg #: 1649690
·
FEI: 3001451826
·
Expires 2026
Products
8
Proprietary Names
2
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Swiss-American CDMO,LLC
- Registration Number
- 1649690
- FEI Number
- 3001451826
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2055 Luna Rd Ste 126
- City
- CARROLLTON
- State
- TX
- ZIP
- 75006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071703
Owner / Operator
- Firm Name
- Swiss-American CDMO, LLC
- Operator Number
- 9020887
- Address
- 2055 LUNA RD., STE. 126, --
- City
- Carrollton
- State
- TX
- Postal Code
- 75006
- Country
- US
- Correspondent
- LESLI M EARLSTON
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2009-04-06 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2025-03-03 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2008-10-29 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2010-02-26 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2007-10-11 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2012-11-06 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2012-11-06 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2012-11-06 |
Proprietary Names
EltaMD Dermal Wound Cleanser
EpiCeram Skin Barrier Emulsion
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device