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
Shenzhen New Industries Biomedical Engineering Co.,Ltd (Shenzhen Guangdong): 4 new FDA device listings, incl. equipment, laboratory, general purpose, labeled or promoted for a spec. Its amount of 4 is above the median of 1 (83rd percentile). Dated 77 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 4 · 83th percentile of 2,570 DeviceEstablishmentPulse records · 4.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 83th of 2,570 (median 1, 4.0x median) |
| Peer records CSV (500 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-20
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Shenzhen New Industries Biomedical Engineering Co.,Ltd and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Shenzhen New Industries Biomedical Engineering Co.,Ltd's amount: 83rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 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.
What is the DeviceEstablishmentPulse record for Shenzhen New Industries Biomedical Engineering Co.,Ltd in Shenzhen Guangdong?
Shenzhen New Industries Biomedical Engineering Co.,Ltd (Shenzhen Guangdong, CN), a manufacturer, added 4 FDA device listings between 2026-05-05 and 2026-08-20.
How does Shenzhen New Industries Biomedical Engineering Co.,Ltd compare to other DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 77 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Shenzhen New Industries Biomedical Engineering Co.,Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Shenzhen New Industries Biomedical Engineering Co.,Ltd | Shenzhen Guangdong, CN | 4 | 83rd | 2026-08-20 |
| Piraeus Medical, Inc. | Maple Grove, MN | 4 | 83rd | 2026-10-12 |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 87th | 2026-10-16 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
Related records
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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.