FDA Registration
Active
🇸🇪 Sweden
Qualisys Clinical System (QCS)
Reg #: 3015786441
·
FEI: 3015786441
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QUALISYS AB
- Registration Number
- 3015786441
- FEI Number
- 3015786441
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kvarnbergsgatan 2
- City
- Goteborg Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K171547
Owner / Operator
- Firm Name
- Qualisys AB
- Operator Number
- 10061206
- Address
- Kvarnbergsgatan 2
- City
- Gothenburg
- State
- Vastra Gotaland
- Postal Code
- 41105
- Country
- SE
- Correspondent
- Nils Betzler
US Agent
- Business Name
- Qualisys North America, Inc.
- Contact Name
- Erik Westerstrom
- Address
- 1603 Barclay Blvd
- City
- Buffalo Grove
- State
- IL
- ZIP
- 60089
- Country
- US
- [email protected]
- Phone
- 847 2122879
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interactive Rehabilitation Exercise Devices | LXJ | Class 2 | Physical Medicine | No | 2019-09-16 |
Proprietary Names
Qualisys Clinical System (QCS)
Establishment Types
Manufacture Medical Device