Philips Health Technology (China) Co., Ltd. Shenyang Branch
Registered establishment in Shenyang, Liaoning, China. 1 device type.
Philips Health Technology (China) Co., Ltd. Shenyang Branch is a specification developer holding a current FDA establishment registration. The registration covers System, X-Ray, Tomography, Computed. Its earliest product listing with the FDA dates from 2022.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3012938564 |
| FEI number | 3012938564 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Shenyang |
|---|---|
| Province | Liaoning |
| Address | Shangshengou Village No.863-6 |
| Postal code | 110167 |
| Country | China |
Group
Philips Health Technology (China) Co., Ltd. Shenyang Branch is one of 5 plants registered under Philips Medical Systems International BV.
| Plant | City | Device types |
|---|---|---|
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | 6 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | 5 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | 5 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | 7 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | Class 2 | Incisive CT, CT 5300, CT Rembra RT, CT Areta RT, CT Rembra | 2022 | 8 |
Clearances
No clearance names Philips Health Technology (China) Co., Ltd. Shenyang Branch as applicant. 3 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 |
|---|---|---|---|---|
| K252992 | 2026-03-23 | JAK | Traditional | Philips Healthcare (Suzhou) Co., Ltd. |
| K232491 | 2024-05-03 | JAK | Traditional | Philips Healthcare (Suzhou) Co., Ltd. |
| K212441 | 2022-04-27 | JAK | Traditional | Philips Healthcare (Suzhou) Co., Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shenyang Ourpromise Medical Equipment Co., Ltd. | 24 |
| Shenyang Henyi Enterprise Co., Ltd. | 11 |
| Shenyang Banzhou Paper Products Co., Ltd. | 5 |
| Sysmed (China) Co., Ltd. | 2 |
| Liaoning Jrsd Commercial AND Trading Co., Ltd. | 2 |
| Shenyang Creative International Trading Company | 1 |
| Shenyang Catch Power FAR Infrared RAY Products Co., Ltd. | 1 |
| Neusoft Medical Systems Co., Ltd. | 1 |
| Shenyang Guangzhen Sewing Co., Ltd. | 1 |
| Liaoning Rachcera Material Technology Co., Ltd. | 1 |
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.