FDA Registration
Active
🇮🇪 Ireland
Kinesis Balance
Reg #: 3011189073
·
FEI: 3011189073
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Linus Health Europe
- Registration Number
- 3011189073
- FEI Number
- 3011189073
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NexusUCD, Belfield Office Park, Clonskeagh
- City
- Dublin 4
- Country
- IE
Owner / Operator
- Firm Name
- Linus Health Europe
- Operator Number
- 10047102
- Address
- NexusUCD, Belfield Office Park,, Clonskeagh
- City
- Dublin 4
- State
- IE-D
- Postal Code
- D04 V2N9
- Country
- IE
US Agent
- Business Name
- Linus Health
- Contact Name
- Suj Shah
- Address
- 280 Summer Street, 10th Floor
- City
- Boston
- State
- MA
- ZIP
- 02210
- Country
- US
- [email protected]
- Phone
- 224 6393068
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fall Prevention Alarm/Sensor Attached Only | PJP | Class 1 | General Hospital | No | 2020-08-31 |
Proprietary Names
Kinesis Balance
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device