Contract manufacturerGyrus ACMI, Inc. (Brooklyn Park, MN)MinnesotaGeneral and plastic surgeryClass II
Gyrus ACMI, Inc.
Contract manufacturer · Brooklyn Park, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011050570 (openFDA record; or search FDA's registration database)
- FEI number
- 3011050570
- Registered for
- FDA registration year 2027
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- OLYMPUS CORPORATION (FDA owner/operator no. 9067818)
- Registered address
- 9600 Louisiana Ave North, Brooklyn Park, MN 55445
- Contract listings
- 1 device listings, 1 product codes, first listed Aug 23, 2017
- 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 |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Aug 23, 2017 |