FDA Registration
Active
🇸🇪 Sweden
0047-T Elite and Precision Imaging Table
Reg #: 9616014
·
FEI: 3002675731
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ARCOMA AB
- Registration Number
- 9616014
- FEI Number
- 3002675731
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ANNAVAGEN 1
- City
- VAXJO Kronoberg
- Country
- SE
Owner / Operator
- Firm Name
- ARCOMA AB
- Operator Number
- 9035990
- Address
- ANNAVAGEN 1, --
- City
- VAXJO
- State
- SE-NOTA
- Postal Code
- SE-325 46
- Country
- SE
- Correspondent
- Henrik Blomdahl
US Agent
- Business Name
- Tara Systems Inc.
- Contact Name
- Gary Becker
- Address
- 19240 Inkwood Ct.
- City
- Boca Raton
- State
- FL
- ZIP
- 33498
- Country
- US
- [email protected]
- Phone
- 561 2126985
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Table, Radiographic, Tilting | IXR | Class 2 | Radiology | No | 2007-02-26 |
Proprietary Names
0047-T Elite and Precision Imaging Table
0047-BT Urology table
0047-CV Vascular Imaging Table
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device