FDA Registration
Active
🇺🇸 United States
EKLA CORPORATION
Reg #: 3008733163
·
FEI: 3008733163
·
Expires 2026
Products
5
Proprietary Names
16
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- EKLA CORPORATION
- Registration Number
- 3008733163
- FEI Number
- 3008733163
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1707 Quincy Ave Ste 127
- City
- Naperville
- State
- IL
- ZIP
- 60540
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163135
Owner / Operator
- Firm Name
- EKLA Corporation
- Operator Number
- 10035863
- Address
- 1707 Quincy Ave. Suite 127
- City
- Naperville
- State
- IL
- Postal Code
- 60540
- Country
- US
- Correspondent
- Erin Lu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-01-21 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-08-05 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-08-08 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-08-08 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2023-05-01 |
Proprietary Names
EKLA FINGER PULSE OXIMETER, E02-1001
NOVAPLUS FINGER PULSE OXIMETER, V02-1001
EKLA Infrared Forehead Thermometer; EDTT-1B, VDTT-1B
EKLA Push Button Blood Collection FPA Set, administration, intravascular
EKLA 500cc Pressure Infusion Bag with mesh back
EKLA 1000cc Pressure Infusion Bag with mesh back
EKLA 3000cc Pressure Infusion Bag with clear back
EKLA 500cc Pressure Infusion Bag with clear back
EKLA 3000cc Pressure Infusion Bag with mesh back
EKLA 1000cc Pressure Infusion Bag with clear back
EKLA Stick Digital Thermometer; EDTT-100U, E01-1008
NOVAPLUS Stick Digital Thermometer; VDTS-100B, VDTS-100R, VDTS-100U
EKLA Stick Digital Thermometer; EDTS-100B, EDTS-100R, EDTS-100U
EKLA Digital Stick Thermometer; V01-1008
NOVAPLUS Stick Digital Thermometer; VDTS-100D, VDTS-100F, VDTS-100RF and VDTF-100U
EKLA Stick Digital Thermometer; EDTS-100D, EDTS-100F, EDTF-100U EDTS-100RF
Establishment Types
Repack or Relabel Medical Device