Contract manufacturerTIERCEL SURGICAL (New Britain, PA)PennsylvaniaCardiovascularClass II
TIERCEL SURGICAL
Contract manufacturer · New Britain, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3027595864 (openFDA record; or search FDA's registration database)
- FEI number
- 3027595864
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Tiercel Surgical (FDA owner/operator no. 10088298)
- Registered address
- 75 Britain Drive, New Britain, PA 18901
- Contract listings
- 3 device listings, 2 product codes, first listed Jun 26, 2023
- 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 |
|---|---|---|---|---|---|
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract manufacturing | Jun 26, 2023 |
| QEY | Mechanical Thrombolysis Catheter | Class II | Cardiovascular | Contract manufacturing | Jun 26, 2023 |