Jiangsu Konsung BIO-Medical Science AND Technology Co Ltd
Manufacturer and brand owner in Danyang, Jiangsu, China. 2 device types, 2 products catalogued, 1 clearance.
Jiangsu Konsung BIO-Medical Science AND Technology Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Generator, Oxygen, Portable. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016859940 |
| FEI number | 3016859940 |
| DUNS | 544307339 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 江苏康尚生物医疗科技有限公司 |
|---|---|
| Unified social credit code | 913211810618686552 |
| Source | NMPA UDI database |
Location
| City | Danyang |
|---|---|
| Province | Jiangsu |
| Address | No.8,Shengchang West Road, Danyang Development Zone, |
| Postal code | 212300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Generator, Oxygen, Portable | Class 2 | oxygen concentrator (Model: KSW-5, KSN-5, KSOC-5) | 2023 | 22 |
| Oximeter | Class 2 | Fingertip Pulse Oximeter models SONOSAT-F01T, SONOSAT-F02T, Wrist Pulse Oximeter model SONOSAT-W01T | 2020 | 70 |
Own-Brand Listings
Clearances
1 clearance names Jiangsu Konsung BIO-Medical Science AND Technology Co Ltd as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K223740 | 2023-10-05 | CAW | Traditional | This company |
| K152091 | 2016-08-18 | DQA | Traditional | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. |
| K152089 | 2016-08-17 | DQA | Traditional | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | Sleep Apnoea Breathing Therapy Devices, Oxygen Concentrator, Pulse Oximeter, Multi-parameter Health Examination System, Patient Monitor |
| Certifications | ISO13485, CE certification, Jiangsu specialized and innovative enterprise, Jiangsu Industrial Design Center |
| Export markets | Global (MEDICA 2023 Germany, ADLM Chicago exhibitions) |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.