Altek Medical (Kunshan) Limited
Registered establishment in Kunshan Free Trade Zone, Jiangsu, China. 2 device types.
Altek Medical (kunshan) limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Camera, Still, Surgical, System, Test, Blood Glucose, Over The Counter. Its earliest product listing with the FDA dates from 2009.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3022346573 |
| FEI number | 3022346573 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 荣晶医疗科技（昆山）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Kunshan Free Trade Zone |
|---|---|
| Province | Jiangsu |
| Address | 2F, Building No.1, No. 77, 3rd Main Street |
| Postal code | 215301 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Camera, Still, Surgical | Class 1 | Pilot Program Participants Only | 2009 | 1 |
| System, Test, Blood Glucose, Over The Counter | Class 2 | IWLCaretech Blood Glucose Monitoring System, Accu-Chek Instant Blood Glucose Monitoring System, Accu-Chek Guide Me Blood Glucose Monitoring System, IWL2020 Blood Glucose Monitoring System | 2021 | 20 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Disposable endoscope, Glucose meter, CGM solutions, Insulin pump system, Smart injector |
| Certifications | FDA 21 CFR 820, ISO 13485, OHSAS 18001, China GMP, Taiwan QMS |
| OEM and ODM | Offered |
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.