FDA Registration
Active
🇺🇸 United States
PregSense
Reg #: 3010032952
·
FEI: 3010032952
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEKO MedTec Solutions
- Registration Number
- 3010032952
- FEI Number
- 3010032952
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 300 Crown Court, Suite 320
- City
- Oakdale
- State
- PA
- ZIP
- 15071
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191401
Owner / Operator
- Firm Name
- SEKO MedTec Solutions
- Operator Number
- 10042726
- Address
- 100 Walker Drive
- City
- State College
- State
- PA
- Postal Code
- 16801
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Home Uterine Activity Monitor | LQK | Class 2 | Obstetrics/Gynecology | No | 2021-01-28 |
Proprietary Names
PregSense
Establishment Types
Repack or Relabel Medical Device