FDA Registration
Active
🇰🇷 South Korea
I-SENS, INC.
Reg #: 3005621222
·
FEI: 3005621222
·
Expires 2026
Products
5
Proprietary Names
32
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- I-SENS, INC.
- Registration Number
- 3005621222
- FEI Number
- 3005621222
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 43, Banpo-daero 28-gil, Seocho-gu
- City
- SEOUL
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K120351
Owner / Operator
- Firm Name
- i-SENS, Inc.
- Operator Number
- 9083763
- Address
- 43, Banpo-daero 28-gil, Seocho-gu
- City
- Seoul
- State
- KR-11
- Postal Code
- 06646
- Country
- KR
- Correspondent
- Han Wool Kim
US Agent
- Business Name
- i-SENS USA, Inc.
- Contact Name
- Yoon Ha Cha
- Address
- 3545 Lomita Blvd., Unit D
- City
- Torrance
- State
- CA
- ZIP
- 90505
- Country
- US
- [email protected]
- Phone
- 607 3771441
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2012-07-18 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2012-07-18 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-12-02 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2022-12-01 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2020-09-09 |
Proprietary Names
CareSens N POP Blood Glucose Monitoring System
GLUCOCARD Shine Blood Glucose Monitoting System
Fifty 50 Blood Glucose Monitoring System 2 Sport
Greater Goods Essential Blood Glucose Monitoring System
ReliOn Premier BLU Blood Glucose Monitoring System
CareSens N Voice Multi Blood Glucose Monitoring System
LDE4 Lancing Device
GLUCOCARD Shine Express Blood Glucose Monitoring System
GLUCOCARD Shine Connex Blood Glucose Monitoring System
CareSens N Voice Square Blood Glucose Monitoring System
CareSens S Clear BT Blood Glucose Monitoring System
Tempo Blood Glucose Monitoring System
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
Assure Prism multi Blood Glucose Monitoring System
CareSens S Fit Blood Glucose Monitoring System
GLUCOCARD Shine Control Solution
GLUCOCARD Shine XL Blood Glucose Monitoring System
CareSens N Blood Glucose Monitoring System
KetoSens BT Blood ?-Ketone Monitoring System
KetoSens Blood ?-Ketone Monitoring System
KetoSens Multi Blood ?-Ketone Monitoring System
CareSens N Voice Blood Glucose Monitoring System
ReliOn Premier Voice Blood Glucose Monitoring System
CareSens N Feliz BT Blood Glucose Monitoring System
CareSens N Feliz Blood Glucose Monitoring System
CareSens N Mini Blood Glucose Monitoring System
ReliOn Premier COMPACT Blood Glucose Monitoring System
NoCoding1 Plus Blood Glucose Monitoring System
CareSens N Plus BT Blood Glucose Monitoring System
tenovi Blood Glucose Monitoring System
CareSens S Fit BT Blood Glucose Monitoring System
ReliOn Premier Classic Blood Glucose Monitoring System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility