Data / Medical devices / China / Compai Healthcare (suzhou) Co.,ltd
Compai Healthcare (suzhou) Co.,ltd: FDA-registered device maker in Suzhou Jiangsu, China, 2 510(k) clearances
Compai Healthcare (suzhou) Co.,ltd is registered with the FDA (registration 3017889703) in Suzhou Jiangsu, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017889703
- Address
- Room 3A05, Building 2, No.8 Changting Road,High-tech Zone, Suzhou, Jiangsu, P.R. China, Suzhou Jiangsu, China, 215151
- Owner or operator
- CompAI Healthcare (Suzhou) Co.,ltd (10086645)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 19, 2022
- Registered through
- 2026
- Brand names listed
- QuadraView 100, TrueView 200 Pro-US, TrueView Core 100Pro-US, TureView 100 Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cabinet, X-Ray System | MWP | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2023 | K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | MWP | Substantially Equivalent | Compai Healthcare (Suzhou) Co.,Ltd | accessdata.fda.gov |
| April 24, 2023 | K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | MWP | Substantially Equivalent | Compai Healthcare (Suzhou) Co.,Ltd | accessdata.fda.gov |
Compare with other makers
Updated April 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.