FDA Registration
Active
🇺🇸 United States
ANCORIS
Reg #: 1423348
·
FEI: 3000210013
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MIE AMERICA, INC.
- Registration Number
- 1423348
- FEI Number
- 3000210013
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 420 BENNETT RD.
- City
- ELK GROVE VILLAGE
- State
- IL
- ZIP
- 60007
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201807
Owner / Operator
- Firm Name
- MIE GMBH
- Operator Number
- 9028781
- Address
- Hauptstrasse 112, --
- City
- Seth
- State
- DE-NOTA
- Postal Code
- 23845
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2020-11-03 |
Proprietary Names
ANCORIS
Establishment Types
Complaint File Establishment per 21 CFR 820.198