# GaleMed (Xiamen) Co., Ltd. (contract manufacturer, XIAMEN Fujian, CN): 1 new FDA device listing, incl. mask, oxygen, non-rebreathing

**Score:** 40/100

| Field | Value |
|---|---|
| Establishment | GaleMed (Xiamen) Co., Ltd. |
| Owner / operator | GaleMed Corporation |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | XIAMEN Fujian, CN |
| New listings | 1 |
| Devices | Mask, Oxygen, Non-Rebreathing |
| Product codes | KGB |
| Device classes | Class I |
| Medical specialties | Anesthesiology |
| Brand names | OM-2 HiO2 Mask, Child w/Tubing, PVC Bag; OM-2 HiO2 Mask, Adult w/Tubing, PVC Bag; OM-2 HiO2 Mask, Child w/Tubing |
| First new listing | 2026-09-17 |
| Latest new listing | 2026-09-17 |
| FDA registration number | 3006783791 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.

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.