FDA Registration
Active
🇨🇦 Canada
VENOFER
Reg #: 9680579
·
FEI: 1000203464
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics Radiation Technologies Canada, Inc
- Registration Number
- 9680579
- FEI Number
- 1000203464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1425 KEBET WAY
- City
- PORT COQUITLAM British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K121497
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2017-06-20 |
Proprietary Names
VENOFER
VENOFER PUMP
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)