Contract manufacturerCATHTEK LLC (Walkertown, NC)North CarolinaGastroenterology and urologyOrthopedicClinical chemistryOphthalmicGeneral and plastic surgeryClass IIClass IUnclassified
CATHTEK LLC
Contract manufacturer · Walkertown, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3027553380 (openFDA record; or search FDA's registration database)
- FEI number
- 3027553380
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Cathtek LLC (FDA owner/operator no. 10042470)
- Registered address
- 4790 Walkertown Plaza Blvd, Walkertown, NC 27051
- Contract listings
- 7 device listings, 6 product codes, first listed Dec 6, 2014
- 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 |
|---|---|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology and urology | Contract manufacturing | Jul 19, 2024 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Jun 12, 2026 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 26, 2025 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class II | Clinical chemistry | Contract manufacturing | Nov 25, 2020 |
| OTZ | Graft Insertion Instrument For Endothelial Keratoplasty | Class I | Ophthalmic | Contract manufacturing | Dec 6, 2014 |
| PHU | Intra-Abdominal Pressure Monitoring Device | Unclassified | General and plastic surgery | Contract manufacturing | Jul 19, 2024 |