FDA Registration
Active
🇸🇪 Sweden
Unite Connect for Clinical Systems
Reg #: 3008952681
·
FEI: 3008952681
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ASCOM SWEDEN AB
- Registration Number
- 3008952681
- FEI Number
- 3008952681
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Grimbodalen 2
- City
- Goteborg Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K180566
Owner / Operator
- Firm Name
- ASCOM SWEDEN AB
- Operator Number
- 10037837
- Address
- 300 Perimeter Park Drive
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2019-04-18 |
Proprietary Names
Unite Connect for Clinical Systems
Establishment Types
Manufacture Medical Device