Contract manufacturerRoechling Medical Lancaster, LLC (Denver, PA)PennsylvaniaOrthopedicCardiovascularGeneral and plastic surgeryOphthalmicHematologyClass IIClass I
Roechling Medical Lancaster, LLC
Contract manufacturer ยท Denver, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2531321 (openFDA record; or search FDA's registration database)
- FEI number
- 3001237758
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Roechling Medical Rochester, L.P. (FDA owner/operator no. 10048821)
- Registered address
- 44 DENVER RD., Denver, PA 17517
- Contract listings
- 8 device listings, 6 product codes, first listed Jul 10, 2018
- 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 |
|---|---|---|---|---|---|
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Jul 10, 2018 |
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract manufacturing | Jul 10, 2018 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract manufacturing | Jul 10, 2018 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | Class II | General and plastic surgery | Contract manufacturing | Nov 22, 2019 |
| NGY | Cannula, Trocar, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Jul 10, 2018 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract manufacturing | Jul 10, 2018 |