FDA Registration
Active
🇺🇸 United States
PIE Device
Reg #: 1061032
·
FEI: 1000511598
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- EDERMY LLC
- Registration Number
- 1061032
- FEI Number
- 1000511598
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 115 Enterprise Drive STE. A
- City
- Pendergrass
- State
- GA
- ZIP
- 30567
- Country
- US
Regulatory Submissions
- 510(k) Number
- K863539
Owner / Operator
- Firm Name
- Edermy LLC
- Operator Number
- 10083992
- Address
- 115 Enterprise Drive STE. A
- City
- Pendergrass
- State
- GA
- Postal Code
- 30567
- Country
- US
- Correspondent
- Mahesh Moolani
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colonic Irrigation System | KPL | Class 2 | Gastroenterology, Urology | No | 2022-01-06 |
Proprietary Names
PIE Device
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device