FDA Registration
Active
🇸🇪 Sweden
NAVOYCDS
Reg #: 3034211429
·
FEI: 3034211429
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ALGODX AB
- Registration Number
- 3034211429
- FEI Number
- 3034211429
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gotgatan 22A
- City
- Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K240558
Owner / Operator
- Firm Name
- AlgoDx AB
- Operator Number
- 10092080
- Address
- PO Box 559173-7985
- City
- Stockholm
- State
- SE-AB
- Postal Code
- 106 31
- Country
- SE
- Correspondent
- Andreas Macura
US Agent
- Business Name
- AlgoDx LLC
- Contact Name
- David Becedas
- Address
- 1 Broadway
- City
- Cambridge
- State
- MA
- ZIP
- 02142
- Country
- US
- [email protected]
- Phone
- 617 4590473
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multivariate Vital Signs Index | PLB | Class 2 | Cardiovascular | No | 2024-12-03 |
Proprietary Names
NAVOYCDS
Establishment Types
Manufacture Medical Device