Contract manufacturerACERTARA ACOUSTIC LABORATORIES, LLC (Longmont, CO)ColoradoRadiologyClass II
ACERTARA ACOUSTIC LABORATORIES, LLC
Contract manufacturer ยท Longmont, CO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3012665486 (openFDA record; or search FDA's registration database)
- FEI number
- 3012665486
- Registered for
- FDA registration year 2027
- Establishment types
- Contract manufacturer
- Owner or operator
- Acertara Acoustic Laboratories, LLC (FDA owner/operator no. 10059427)
- Registered address
- 1950 Lefthand Creek Lane, Longmont, CO 80501
- Contract listings
- 1 device listings, 2 product codes, first listed Oct 9, 2026
- 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 |
|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract manufacturing | Oct 9, 2026 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract manufacturing | Oct 9, 2026 |