Data / Medical devices / China / Shandong Wego Ruisheng Medical Device Co.,ltd
Shandong Wego Ruisheng Medical Device Co.,ltd: FDA-registered device maker in Weihai Shandong, China, 1 510(k) clearance
Shandong Wego Ruisheng Medical Device Co.,ltd is registered with the FDA (registration 3033813683) in Weihai Shandong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 1, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3033813683
- Address
- No.1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai Shandong, China, 264210
- Owner or operator
- Shandong Wego Ruisheng Medical Device Co.,Ltd (10091582)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 17, 2024
- Registered through
- 2026
- Brand names listed
- Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 1, 2024 | K233477 | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) | MQL | Substantially Equivalent | Shandong Wego Ruisheng Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 1, 2024. 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.