FDA Registration
Active
🇮🇪 Ireland
Pillsense capsule
Reg #: 3038614705
·
FEI: 3038614705
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SAFE LIFE HEALTHCARE LTD
- Registration Number
- 3038614705
- FEI Number
- 3038614705
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 3, Racecourse Technology Park Ballybrit
- City
- Galway
- Country
- IE
Regulatory Submissions
- 510(k) Number
- DEN220065
Owner / Operator
- Firm Name
- Safe Life Healthcare Ltd
- Operator Number
- 10093289
- Address
- Unit 3, Racecourse Technology Park Ballybrit
- City
- Galway
- State
- IE-G
- Postal Code
- H91RHR8
- Country
- IE
- Correspondent
- Sean Boyle
US Agent
- Business Name
- Freyr Inc
- Contact Name
- Shilpa Gampa
- Address
- 150 College Road West, Suite 102 Princeton
- City
- Princeton
- State
- NJ
- ZIP
- 08540
- Country
- US
- [email protected]
- Phone
- 760 5834401
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Detection Capsule | QUD | Class 2 | Gastroenterology, Urology | No | 2025-04-24 |
Proprietary Names
Pillsense capsule
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)