Contract manufacturerAptyx - Charlotte (Charlotte, NC)North CarolinaGeneral hospitalGeneral and plastic surgeryGastroenterology and urologyOrthopedicCardiovascularRadiologyClass IIClass IClass III
Aptyx - Charlotte
Contract manufacturer · Charlotte, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011324393 (openFDA record; or search FDA's registration database)
- FEI number
- 3011324393
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer
- Owner or operator
- Aptyx (FDA owner/operator no. 10058611)
- Registered address
- 8531 Steele Creek Place Drive, Suite D, Charlotte, NC 28273
- Contract listings
- 7 device listings, 9 product codes, first listed Feb 12, 2025
- 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 |
|---|---|---|---|---|---|
| BYZ | Trap, Sterile Specimen | Class II | General hospital | Contract manufacturing | Feb 12, 2025 |
| KGS | Retention Device, Suture | Class I | General and plastic surgery | Contract manufacturing | Feb 12, 2025 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Class II | Gastroenterology and urology | Contract manufacturing | Feb 12, 2025 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Feb 12, 2025 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Feb 12, 2025 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract manufacturing | May 23, 2025 |
| QSK | Hybrid Stent Graft, Thoracic Aortic Lesion Treatment | Class III | Cardiovascular | Contract manufacturing | Feb 12, 2025 |
| QXR | Vaginal Hydrogel Packing System | Class II | Radiology | Contract manufacturing | Feb 12, 2025 |
| SEQ | Covered Stent Vascular Connector, Hemodialysis Access Circuit | Class III | Cardiovascular | Contract manufacturing | Aug 20, 2025 |