FDA Registration
Active
🇨🇳 China
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD
Reg #: 3016859940
·
FEI: 3016859940
·
Expires 2026
Products
7
Proprietary Names
31
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD
- Registration Number
- 3016859940
- FEI Number
- 3016859940
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.8,Shengchang West Road, Danyang Development Zone,
- City
- Danyang Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152089
Owner / Operator
- Firm Name
- Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
- Operator Number
- 10066875
- Address
- NO.8, Shengchang West Road, Danyang Development Zone
- City
- Danyang
- State
- Jiangsu
- Postal Code
- 212300
- Country
- CN
- Correspondent
- Baohong Li
US Agent
- Business Name
- Carrasco
- Contact Name
- Mateo Carrasco
- Address
- 1815 Barker drive
- City
- Winter Park
- State
- FL
- ZIP
- 32789
- Country
- US
- [email protected]
- Phone
- 407 2849480
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2021-08-06 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-04-05 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2025-12-02 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2023-10-12 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2022-08-01 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2023-02-14 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2022-08-12 |
Proprietary Names
Fingertip Pulse Oximeter( SONOSAT-K01P, SONOSAT-K02P,SONOSAT-K01LP, SONOSAT-K02LP)
Fingertip Pulse Oximeter (SONOSAT-K01SW,SONOSAT-K02SW,SONOSAT-K01T, SONOSAT-K02T,SONOSAT-K01LT, SONOSAT-K02LT)
Fingertip Pulse Oximeter (SONOSAT-K01R, SONOSAT-K02R,SONOSAT-K01SR, SONOSAT-K02SR,SONOSAT-K01W, SONOSAT-K02W)
Wrist Pulse Oximeter model SONOSAT-W01T
Uric acid test card (dry chemical method) DiaCard-11
Fingertip Pulse Oximeter models SONOSAT-F01T, SONOSAT-F02T
oxygen concentrator (Model: KSW-5, KSN-5, KSOC-5)
Portable Dry Biochemical Analyzer(Compass2800-1, Compass2800-2)
Blood Lipid Test Card (Dry Chemical Method) DiaCard-2
Lipid Analyzer(Compass2600-1,Compass2600-2)
Total cholesterol, uric acid test card (dry chemical method) DiaCard-9
Total cholesterol test card (dry chemical method) DiaCard-10
Colloidal Gold Immunoassay Analyzer iQ2100-4
Colloidal Gold Immunoassay Analyzer iQ2300-3
Colloidal Gold Immunoassay Analyzer iQ2100-3
Colloidal Gold Immunoassay Analyzer iQ2100-1
Colloidal Gold Immunoassay Analyzer iQ2200-2
Colloidal Gold Immunoassay Analyzer iQ2200-4
Colloidal Gold Immunoassay Analyzer iQ2200-6
Luteinizing hormone Rapid Test Kit (Colloidal Gold) FLHC-103G-1
Colloidal Gold Immunoassay Analyzer iQ2300-1
Colloidal Gold Immunoassay Analyzer iQ2300-2
Colloidal Gold Immunoassay Analyzer iQ2000-3
Colloidal Gold Immunoassay Analyzer iQ2000-2
Colloidal Gold Immunoassay Analyzer iQ2200-5
Colloidal Gold Immunoassay Analyzer iQ2300-4
Colloidal Gold Immunoassay Analyzer iQ2200-1
Colloidal Gold Immunoassay Analyzer iQ2100-2
Colloidal Gold Immunoassay Analyzer iQ2000-4
Colloidal Gold Immunoassay Analyzer iQ2200-3
Colloidal Gold Immunoassay Analyzer iQ2000-1
Establishment Types
Manufacture Medical Device