FDA Registration
Active
🇺🇸 United States
EMED TECHNOLOGIES CORPORATION
Reg #: 2523167
·
FEI: 2523167
·
Expires 2026
Products
5
Proprietary Names
16
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- EMED TECHNOLOGIES CORPORATION
- Registration Number
- 2523167
- FEI Number
- 2523167
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1262 Hawks Flight Ct Ste 200
- City
- EL DORADO HILLS
- State
- CA
- ZIP
- 95762
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161906
Owner / Operator
- Firm Name
- EMED Technologies Corporation
- Operator Number
- 2523167
- Address
- 1262 Hawks Flight Court, Suite 200
- City
- El Dorado Hills
- State
- CA
- Postal Code
- 95762
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunoglobulin G (Igg) Infusion System | PKP | Class 2 | General Hospital | No | 2022-10-21 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-01-10 |
| Introducer, Syringe Needle | KZH | Class 2 | General Hospital | No | 2022-10-21 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2010-05-10 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2026-01-05 |
Proprietary Names
SCIg60 Infusion System
VersaRate Flow Rate Controller
SCIg60 Infuser
AccuSert
SUB-Q
SAF-Q
OPTflow
Infuset
FLO
VersaPump Infuser
VersaPump Infusion System
SCIg Set
SUB
Tetra
Infuset Flow Control Extension Set
Infuset Flow Control Infusion Set
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility