Data / Medical devices / China / embecta Medical Devices (Suzhou) Co., Ltd.
embecta Medical Devices (Suzhou) Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
embecta Medical Devices (Suzhou) Co., Ltd. is registered with the FDA (registration 3027605735) in Suzhou Jiangsu, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027605735
- Address
- No.1 Liangpu Street Suzhou Industrial Park, Suzhou Jiangsu, China, --
- Owner or operator
- embecta Corp. (10084714)
- Roles
- Manufacturer
- First device listed
- October 19, 2022
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | 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 |
|---|---|---|---|---|---|---|
| June 28, 2022 | K213478 | BD Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Compare with other makers
Updated June 28, 2022. 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.