Contract manufacturerDSM Biomedical, Inc. (Exton, PA)PennsylvaniaGeneral hospitalGeneral and plastic surgeryNeurologyOrthopedicDentalClass IIClass IClass III
DSM Biomedical, Inc.
Contract manufacturer · Exton, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2530154 (openFDA record; or search FDA's registration database)
- FEI number
- 1000307073
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- DSM BIOMEDICAL (FDA owner/operator no. 9020253)
- Registered address
- 735 Pennsylvania Dr, Exton, PA 19341
- Contract listings
- 28 device listings, 18 product codes, first listed Dec 5, 2011
- 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 |
|---|---|---|---|---|---|
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Jan 9, 2013 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract manufacturing | Dec 5, 2011 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract manufacturing | Dec 5, 2011 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract manufacturing | Jan 25, 2013 |
| GAP | Suture, Nonabsorbable, Silk | Class II | General and plastic surgery | Contract manufacturing | Jan 22, 2013 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract manufacturing | Aug 12, 2016 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Class II | Neurology | Contract manufacturing | Dec 5, 2011 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| JDZ | Mixer, Cement, For Clinical Use | Class I | Orthopedic | Contract manufacturing | Jan 25, 2013 |
| JEY | Plate, Bone | Class II | Dental | Contract manufacturing | Dec 5, 2011 |
| LYC | Bone Grafting Material, Synthetic | Class II | Dental | Contract manufacturing | Nov 12, 2012 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract manufacturing | Dec 5, 2011 |
| NOX | Filler, Bone Void, Synthetic Peptide | Class III | Orthopedic | Contract manufacturing | Apr 30, 2020 |
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | Class II | Orthopedic | Contract manufacturing | Nov 15, 2021 |