# Hebei Lufen Tech Co., Limited (contract sterilizer, Xingtai Hebei, CN): 3 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter

**Score:** 70/100

| 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 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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: 2026-10-28T20:51:27.468Z.
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.