Embecta Medical Devices (Suzhou) Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 1 device type.
embecta Medical Devices (Suzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Needle, Hypodermic, Single Lumen. Its earliest product listing with the FDA dates from 2022.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3027605735 |
| FEI number | 3027605735 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No.1 Liangpu Street |
| Postal code | — |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Needle, Hypodermic, Single Lumen | Class 2 | 2022 | 71 |
Clearances
No clearance names embecta Medical Devices (Suzhou) Co., Ltd. as applicant. One is 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 |
|---|---|---|---|---|
| K213478 | 2022-06-28 | FMI | Traditional | Becton, Dickinson AND Company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2023 |
|---|---|
| Main products | Insulin delivery devices, Pen needles, Syringes |
| Export markets | China, United States, Asia-Pacific, Europe, Middle East |
| OEM and ODM | Not offered |
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.