FDA Registration
Active
🇨🇦 Canada
Reliance EPS Endoscope Processing System (QB-CFE)
Reg #: 9680353
·
FEI: 3004097451
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STERIS Canada ULC
- Registration Number
- 9680353
- FEI Number
- 3004097451
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 490 Boulevard Armand-Paris
- City
- QUEBEC
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K203223
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS Corporation
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Germicide, Cleaning, For Endoscopes | NZA | Class 2 | Gastroenterology, Urology | No | 2021-03-12 |
Proprietary Names
Reliance EPS Endoscope Processing System (QB-CFE)
Flow Units (#1-11) (QB-MF)
DG Germicide (D5100) (MM-MF)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198