FDA Registration
Active
🇸🇪 Sweden
AMRA Profiler
Reg #: 3021593788
·
FEI: 3021593788
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AMRA MEDICAL AB
- Registration Number
- 3021593788
- FEI Number
- 3021593788
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Badhusgatan 5
- City
- Linkoping Ostergotland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K211983
Owner / Operator
- Firm Name
- AMRA Medical AB
- Operator Number
- 10084178
- Address
- Badhusgatan 5
- City
- Linköping
- State
- Ostergotland
- Postal Code
- 58222
- Country
- SE
US Agent
- Business Name
- Medes USA C/O Matan Arazy
- Contact Name
- Benny Arazy
- Address
- 15201 6th Ave NE, ,
- City
- Shoreline
- State
- WA
- ZIP
- 98155
- Country
- US
- [email protected]
- Phone
- 415 9921126
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2022-01-24 |
Proprietary Names
AMRA Profiler
Establishment Types
Manufacture Medical Device