FDA Registration
Active
🇺🇸 United States
RigiScan Plus Rigidity Assessment System
Reg #: 3011027014
·
FEI: 3011027014
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GOTOP MEDICAL INC
- Registration Number
- 3011027014
- FEI Number
- 3011027014
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1000 Westgate Dr Ste 125
- City
- Saint Paul
- State
- MN
- ZIP
- 55114
- Country
- US
Regulatory Submissions
- 510(k) Number
- K941781
Owner / Operator
- Firm Name
- GOTOP Medical Inc
- Operator Number
- 10047270
- Address
- 1000 Westgate Drive, Suite 125
- City
- Saint Paul
- State
- MN
- Postal Code
- 55114
- Country
- US
- Correspondent
- Gordon Gui
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Penile Tumescence | LIL | Class U | Unknown | No | 2014-07-30 |
Proprietary Names
RigiScan Plus Rigidity Assessment System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device