# Shenzhen New Industries Biomedical Engineering Co.,Ltd (manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. equipment, laboratory, general purpose, labeled or promoted for a spec

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Shenzhen New Industries Biomedical Engineering Co.,Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 4 |
| Devices | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; System, Test, Vitamin D |
| Product codes | LXG, JJE, MRG |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry |
| Brand names | SATLARS T8 Laboratory Automation System; MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer; MAGLUMI 25-OH Vitamin D; MAGLUMI X10 Fully-auto chemiluminescence immunoassay analyzer; MAGLUMI X8 Fully-auto chemiluminescence immunoassay analyzer |
| First new listing | 2026-05-05 |
| Latest new listing | 2026-08-20 |
| FDA registration number | 3010610113 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.