Contract manufacturerECA MEDICAL INSTRUMENTS (Newbury Park, CA)CaliforniaCardiovascularGeneral and plastic surgeryNeurologyOrthopedicClass IClass IIClass III
ECA MEDICAL INSTRUMENTS
Contract manufacturer · Newbury Park, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010052483 (openFDA record; or search FDA's registration database)
- FEI number
- 3010052483
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- ECA Medical Instruments (FDA owner/operator no. 10042970)
- Registered address
- 1107 Tourmaline Drive, Newbury Park, CA 91320
- Contract listings
- 19 device listings, 19 product codes, first listed Jan 16, 2013
- 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 |
|---|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | Dec 21, 2018 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jun 11, 2025 |
| HAO | Instrument, Surgical, Non-Powered | Class I | Neurology | Contract manufacturing | Dec 21, 2018 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 15, 2023 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Jun 11, 2025 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 15, 2023 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Feb 28, 2023 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Jun 21, 2023 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Jun 11, 2025 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jun 11, 2025 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract manufacturing | Jan 12, 2024 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Class III | Neurology | Contract manufacturing | Feb 10, 2023 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jan 16, 2013 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Oct 18, 2024 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Class III | Neurology | Contract manufacturing | Feb 10, 2023 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Class III | Neurology | Contract manufacturing | Feb 10, 2023 |
| NWN | Laparoscopic Bone Anchor Urethropexy Instrument Kit | Class II | Orthopedic | Contract manufacturing | May 21, 2025 |
| OJH | Orthopedic Tray | Class I | General and plastic surgery | Contract manufacturing | Apr 15, 2026 |
| PJS | Stimulator, Electrical, Implanted, For Essential Tremor | Class III | Neurology | Contract manufacturing | Feb 10, 2023 |