Contract manufacturerDymax, Corp. (Zelienople, PA)PennsylvaniaCardiovascularGastroenterology and urologyGeneral hospitalGeneral and plastic surgeryRadiologyClass IIClass I
Dymax, Corp.
Contract manufacturer · Zelienople, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3013041594 (openFDA record; or search FDA's registration database)
- FEI number
- 3013041594
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Remanufacturer; Repackager or relabeler
- Owner or operator
- C. R. Bard, Inc. (FDA owner/operator no. 2212754)
- Registered address
- 141 Zehner School Rd, Zelienople, PA 16063
- Contract listings
- 25 device listings, 12 product codes, first listed May 23, 2005
- 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 |
|---|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Class II | Cardiovascular | Contract manufacturing | Sep 7, 2016 |
| EXS | Urinometer, Electrical | Class II | Gastroenterology and urology | Contract manufacturing | Feb 24, 2012 |
| FOX | Stand, Infusion | Class I | General hospital | Contract manufacturing | Jan 23, 2014 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract manufacturing | Mar 26, 2026 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract manufacturing | May 23, 2005 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | Contract manufacturing | Mar 12, 2010 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract manufacturing | Oct 23, 2007 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract manufacturing | Jan 8, 2009 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class II | General hospital | Contract manufacturing | Oct 22, 2007 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract manufacturing | Mar 12, 2010 |
| LRJ | Disinfectant, Medical Devices | Class I | General hospital | Contract manufacturing | Oct 28, 2020 |
| NZU | Collector, Urine, Powered, Non Indwelling Catheter | Class I | Gastroenterology and urology | Contract manufacturing | Jan 10, 2018 |