FDA Registration
Active
🇨🇦 Canada
Disposable blood collection set
Reg #: 3007501254
·
FEI: 3007501254
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DOMREX PHARMA INC.
- Registration Number
- 3007501254
- FEI Number
- 3007501254
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 269 rue Robinson
- City
- Saint-Eustache Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K151991
Owner / Operator
- Firm Name
- DOMREX PHARMA INC.
- Operator Number
- 10078102
- Address
- 269 rue Robinson
- City
- Saint-Eustache
- State
- Quebec
- Postal Code
- J7R 5V7
- Country
- CA
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2023-12-17 |
Proprietary Names
Disposable blood collection set
Safelock disposable blood collection set
Establishment Types
Export Device to the United States But Perform No Other Operation on Device