FDA Registration
Active
🇯🇵 Japan
PBD-1030-1007
Reg #: 8010047
·
FEI: 3002807795
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Registration Number
- 8010047
- FEI Number
- 3002807795
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI Tokyo
- Country
- JP
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
US Agent
- Business Name
- Gyrus ACMI, Inc.
- Contact Name
- Todd Brill
- Address
- 800 West Park Drive, --
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2024-06-07 |
Proprietary Names
PBD-1030-1007
PBD-1030-1015
PBD-1030-0707
PBD-1030-0712
PBD-1030-1012
PBD-1030-0709
PBD-1030-0715
PBD-1030-1009
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility