Contract manufacturerKOBAYASHI AMERICA MANUFACTURING, LLC (Dalton, GA)GeorgiaPhysical medicineClass I
KOBAYASHI AMERICA MANUFACTURING, LLC
Contract manufacturer ยท Dalton, GA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003079019 (openFDA record; or search FDA's registration database)
- FEI number
- 3003079019
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- KOBAYASHI AMERICA MANUFACTURING, LLC (FDA owner/operator no. 10049550)
- Registered address
- 245 KRAFT DR, Dalton, GA 30721
- Contract listings
- 2 device listings, 2 product codes, first listed Jun 17, 2015
- 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 |
|---|---|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | Class I | Physical medicine | Contract manufacturing | Jun 17, 2015 |
| OMW | Adhesive Backed Thermal Skin Patches | Class I | Physical medicine | Contract manufacturing | Nov 3, 2017 |