Hebei Lufen Tech Co., Limited (contract sterilizer, Xingtai Hebei, CN): 3 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter
Hebei Lufen Tech Co., Limited (Xingtai Hebei): 3 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter. Its amount of 3 is above the median of 1 (77th percentile). Dated 104 days ago, it serves as a historical benchmark. Score 70/100. 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: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x 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 | Hebei Lufen Tech Co., Limited |
| Role | Contract sterilizer |
| Establishment types | Manufacture Medical Device; Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Xingtai Hebei, CN |
| New listings | 3 |
| Devices | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning |
| Product codes | NUH, NGX |
| Device classes | Class II |
| Medical specialties | Neurology, Physical Medicine |
| Brand names | Electranic Muscle Stimulator:AST-300A, AST-300; ELECTRONIC MUSCLE STIMULATOR; NS EMS Muscle massager, Hiemt emslim machine,EMS8-1 EMS8-2 EMS8-3 EMS8-4 EMS8-5 EMS8-6 EMS8-7 EMS8-8 EMS10,EMS11,EMS12,E |
| First new listing | 2026-06-30 |
| Latest new listing | 2026-07-23 |
| FDA registration number | 3031233199 |
| Registration expires | 2026-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x 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: 2026-07-23
- 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: Hebei Lufen Tech Co., Limited and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Hebei Lufen Tech Co., Limited's amount: 77th 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)
70 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Hebei Lufen Tech Co., Limited in Xingtai Hebei?
Hebei Lufen Tech Co., Limited (Xingtai Hebei, CN), a contract sterilizer, added 3 FDA device listings between 2026-06-30 and 2026-07-23.
How does Hebei Lufen Tech Co., Limited compare to other DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 104 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Hebei Lufen Tech Co., Limited vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Hebei Lufen Tech Co., Limited | Xingtai Hebei, CN | 3 | 77th | 2026-07-23 |
| Isomedix Operations Inc. | Chester, NY | 3 | 77th | 2026-09-28 |
| Isomedix Operations, Inc | Ontario, CA | 7 | 90th | 2026-10-15 |
| Isomedix Operations, Inc. | Libertyville, IL | 7 | 90th | 2026-10-15 |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: Foreign establishment
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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.