FDA Registration
Active
🇸🇪 Sweden
ROSSIX AB
Reg #: 3004075036
·
FEI: 3004075036
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROSSIX AB
- Registration Number
- 3004075036
- FEI Number
- 3004075036
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Taljegardsgatan 3B
- City
- Molndal Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K230852
Owner / Operator
- Firm Name
- Rossix AB
- Operator Number
- 10090697
- Address
- Taljegardsgatan 3B
- City
- Molndal
- State
- Vastra Gotaland
- Postal Code
- 43153
- Country
- SE
- Correspondent
- Pia Bryngelhed
US Agent
- Business Name
- Instrumentation Laboratory Company
- Contact Name
- Carol Marble
- Address
- 180 Hartwell Road
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
- [email protected]
- Phone
- 781 8614467
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Qualitative And Quantitative Factor Deficiency | GGP | Class 2 | Hematology | No | 2024-04-30 |
Establishment Types
Manufacture Medical Device