Compai Healthcare (Suzhou) Co.,Ltd
Suzhou Jiangsu, CN
COMPAI HEALTHCARE (SUZHOU) CO.,LTD appears in FDA device records in Suzhou Jiangsu, CN. FDA records list 2 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Compai Healthcare (Suzhou) Co.,Ltd in 2023.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | MWP | Substantially Equivalent | |
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | MWP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017889703 | 3017889703 | COMPAI HEALTHCARE (SUZHOU) CO.,LTD | Room 3A05, Building 2, No.8 Changting Road,High-tech Zone, Suzhou, Jiangsu, P.R. China, Suzhou Jiangsu 215151 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Compai Healthcare (Suzhou) Co.,Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain