# Hydrochem Co., Ltd (contract manufacturer, Gangeung-Si Gangwon, KR): 7 new FDA device listings, incl. generator, oxygen, portable

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Hydrochem Co., Ltd |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Gangeung-Si Gangwon, KR |
| New listings | 7 |
| Devices | Generator, Oxygen, Portable; Surgical Mask With Antimicrobial/Antiviral Agent; Respirator, Surgical; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Stocking, Medical Support (To Prevent Pooling Of Blood In Legs); Mask, Surgical; Respirator, N95, For Use By The General Public In Public Health Medical Emergencies |
| Product codes | CAW, OUK, MSH, NAE, DWL, FXX, NZJ |
| Device classes | Class I, Class II |
| Medical specialties | Anesthesiology, General, Plastic Surgery, General Hospital |
| Brand names | HC Portable Oxygen Concentrator w/ SOP; Face Mask Surgical, Antimicrobial w/ SOP; O2 Respirator, Surgical w/ SOP; Dressing Wound Bed Sore w/ SOP; Travel Socks, Antimicrobial; Face Mask Surgical w/ SOP, Techno Web; Mask, Oxygen, Fresh Patch w/ SOP |
| First new listing | 2026-05-18 |
| Latest new listing | 2026-05-19 |
| FDA registration number | 3045816954 |
| 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.