FDA Registration
Active
🇺🇸 United States
MAJ-1720
Reg #: 3011050570
·
FEI: 3011050570
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Gyrus ACMI, Inc.
- Registration Number
- 3011050570
- FEI Number
- 3011050570
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9600 Louisiana Ave North
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55445
- Country
- US
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2023-10-30 |
Proprietary Names
MAJ-1720
EU-ME1
MAJ-2381
EU-ME3
MAJ-2383
MAJ-2382
Establishment Types
Complaint File Establishment per 21 CFR 820.198