Data / Medical devices / China / RWD Life Science Co., Ltd.
RWD Life Science Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
RWD Life Science Co., Ltd. is registered with the FDA (registration 3021013124) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 28, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021013124
- Address
- 19F, Building 9A, Vanke Cloud City lll, Liuxin 4 Street, Nanshan District, Shenzhen Guangdong, China, 518000
- Owner or operator
- RWD Life Science Co., Ltd. (10089020)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 29, 2023
- Registered through
- 2026
- Brand names listed
- Cryostat, Cryostat FS800, Cryostat FS800A, Extravascular Blood Flow Probe, High-Speed Benchtop Refrigerated Centrifuge, Laser Speckle Imaging System (RFLSI CZW), M1324, M1324R and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Microtome, Cryostat | IDP | 1 | Manufacturer | accessdata.fda.gov |
| Microtome, Rotary | IDO | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Blood-Flow, Extravascular | DPT | 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 |
|---|---|---|---|---|---|---|
| May 28, 2024 | K233076 | Laser Speckle Imaging System (RFLSI CZW) | DPT | Substantially Equivalent | Rwd Life Science Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of Microtome, Rotary
- All makers of Probe, Blood-Flow, Extravascular
- All makers of Microtome, Cryostat
Updated May 28, 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.