# Guangdong Kelihuan Biotechnology Co., Ltd. (manufacturer, Huizhou Guangdong, CN): 5 new FDA device listings, incl. applicator, ent

**Score:** 60/100

| Field | Value |
|---|---|
| Establishment | Guangdong Kelihuan Biotechnology Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device |
| Location | Huizhou Guangdong, CN |
| New listings | 5 |
| Devices | Applicator, Ent; Cushion, Earphone (For Audiometric Testing); Pad, Eye; Applicator, Absorbent Tipped, Non-Sterile; Nasal Spray, Ent Delivery |
| Product codes | KCJ, ETT, HMP, KXF, KCO |
| Device classes | Class I |
| Medical specialties | Ear, Nose, Throat, General, Plastic Surgery, General Hospital |
| Brand names | Essential Oil Patches 2 patches/bag, 4 patches/bag, 4 patches/box, 6 patches/box, 8 patches/box, 10 patches/box,; 26 patches/box, 28 patches/box, 30 patches/box; 12 patches/box, 14 patches/box, 16 patches/box, 18 patches/box, 20 patches/box, 22 patches/box, 24 patches/box,; SLEEP FRAGRANCE EARPLUGS; SET; ESSENTIAL OIL PATCHES GRAVITY EYE MASK SET; 10 patches/box, 12 patches/box, 14 patches/box, 16 patches/box, 18 patches/box, 20 patches/box; 22 patches/box, 24 patches/box, 26 patches/box, 28 patches/box, 30 patches/box |
| First new listing | 2026-05-23 |
| Latest new listing | 2026-08-09 |
| FDA registration number | 3045975099 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- 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.