Data / Medical devices / China / Shanghai Leyi Plastic Products Co Ltd
Shanghai Leyi Plastic Products Co Ltd: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Shanghai Leyi Plastic Products Co Ltd is registered with the FDA (registration 3010453313) in Shanghai, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 19, 2002. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010453313
- Address
- 209th Honghua Road Zhelin Down, Fengxian District, Shanghai, China, 201417
- Owner or operator
- Shanghai Leyi Plastic Products Co Ltd (10044801)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 31, 2013
- Registered through
- 2026
- Brand names listed
- Emesis Bag
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Ice | KYR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Counter, Sponge, Surgical | LWH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 19, 2002 | K014239 | MEDSURG EQUIPMENT COVERS | MMP | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
Compare with other makers
- All makers of Counter, Sponge, Surgical
- All makers of Bag, Ice
- All makers of Cover, Barrier, Protective
- All makers of Basin, Emesis
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated February 19, 2002. 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.