Contract manufacturerBERKLEY MEDICAL RESOURCES, INC. (Smithfield, PA)PennsylvaniaGeneral and plastic surgeryClass IIClass I
BERKLEY MEDICAL RESOURCES, INC.
Contract manufacturer · Smithfield, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2518423 (openFDA record; or search FDA's registration database)
- FEI number
- 2518423
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer; Contract manufacturer
- Owner or operator
- BERKLEY MEDICAL RESOURCES, INC. (FDA owner/operator no. 2518423)
- Registered address
- 700 Mountain View Dr, Smithfield, PA 15478
- Contract listings
- 2 device listings, 2 product codes, first listed Sep 16, 1992
- 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 |
|---|---|---|---|---|---|
| FXX | Mask, Surgical | Class II | General and plastic surgery | Contract manufacturing | Oct 17, 2014 |
| FYE | Dress, Surgical | Class I | General and plastic surgery | Contract manufacturing | Sep 16, 1992 |