Data / Medical devices / China / Shenzhen New Industries Biomedical Engineering Co.,ltd
Shenzhen New Industries Biomedical Engineering Co.,ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen New Industries Biomedical Engineering Co.,ltd is registered with the FDA (registration 3010610113) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010610113
- Address
- No.23 Jinxiu East Road Pingshan District, Shenzhen Guangdong, China, 518122
- Owner or operator
- Shenzhen New Industries Biomedical Engineering Co.,Ltd (10049797)
- Roles
- Manufacturer
- First device listed
- May 5, 2026
- Registered through
- 2026
- Brand names listed
- MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Vitamin D | MRG | 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 |
|---|---|---|---|---|---|---|
| April 12, 2024 | K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | MRG | Substantially Equivalent | Shenzhen New Industries Biomedical Engineering Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Vitamin D
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Updated April 12, 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.