FDA Registration
Active
🇺🇸 United States
BioGuard air/water cleaning adapter - Olympus (EN-CFE)
Reg #: 1528319
·
FEI: 1000122656
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- UNITED STATES ENDOSCOPY GROUP, INC.
- Registration Number
- 1528319
- FEI Number
- 1000122656
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5976 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2020-10-09 |
Proprietary Names
BioGuard air/water cleaning adapter - Olympus (EN-CFE)
Reliance Endoscope Transport Bin (RETBIN01) (QB-CFE)
Reliance Endoscope Transport Cart (RETCART01) (QB-CFE)
Cleanascope Liner (LC-FE)
Cleanascope Advantage Tray (LC-FE)
Establishment Types
Complaint File Establishment per 21 CFR 820.198