Compai Medtech (Suzhou) Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 1 device type, 1 product catalogued.
Compai Medtech (Suzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cabinet, X-Ray System. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2026.
Registration
| Registered name | COMPAI MEDTECH (SUZHOU) CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3045925649 |
| FEI number | 3045925649 |
| DUNS | 517154080 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | ROOM 3A05, BUILDING 2 |
| Postal code | 215151 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cabinet, X-Ray System | Class 2 | TrueView 200 Pro-US, TrueView Core 100Pro-US | 2026 | 2 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| TrueView | MWP | 2 |
Clearances
No clearance names Compai Medtech (Suzhou) 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 |
|---|---|---|---|---|
| K230136 | 2023-04-24 | MWP | Traditional | Compai Healthcare (Suzhou) Co., Ltd. |
| K230140 | 2023-04-24 | MWP | Traditional | Compai Healthcare (Suzhou) Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Specimen imaging systems, X-ray imaging systems, Medical imaging devices |
|---|---|
| Certifications | ISO13485 |
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.