Hydrochem Co., Ltd (contract manufacturer, Gangeung-Si Gangwon, KR): 7 new FDA device listings, incl. generator, oxygen, portable
Hydrochem Co., Ltd (Gangeung-Si Gangwon): 7 new FDA device listings, incl. generator, oxygen, portable. Its amount of 7 is top-decile (90th percentile of 2,570 records). Dated 169 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: 7 · 90th percentile of 2,570 DeviceEstablishmentPulse records · 7.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 116 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 90th of 2,570 (median 1, 7.0x median) |
| Peer records CSV (117 KR 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: 2026-05-19
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (KR first): Zapalign Inc. (foreign exporter, Anyang-si Gyeonggi, KR) · Samsung Medison Co., Ltd. (manufacturer, Gumi-si Gyeongbuk, · Samsung Medison Co., Ltd. (manufacturer, HONGCHEON-GUN Gangw · Osstem Implant Co.,Ltd. (manufacturer, Yeonsu-gu Incheon, KR · Boditech Med Inc. (manufacturer, Chuncheon Gangwon, KR) · Browse all by state and category →
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: Hydrochem Co., Ltd and 117 KR peers
- KR DeviceEstablishmentPulse records like this one: 117
- Hydrochem Co., Ltd's amount: 90th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $23,400 (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 Hydrochem Co., Ltd in Gangeung-Si Gangwon?
Hydrochem Co., Ltd (Gangeung-Si Gangwon, KR), a contract manufacturer, added 7 FDA device listings between 2026-05-18 and 2026-05-19.
How does Hydrochem Co., Ltd compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 7 is 7.0x the median of 1 across 2,570 records. It is 169 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.
Hydrochem Co., Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Hydrochem Co., Ltd | Gangeung-Si Gangwon, KR | 7 | 90th | 2026-05-19 |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN | 4 | 83rd | 2026-10-16 |
| Cook Medical LLC | Bloomington, IN | 4 | 83rd | 2026-10-13 |
| Swiss-American CDMO,LLC | Carrollton, TX | 4 | 83rd | 2026-10-12 |
Related records
DeviceEstablishmentPulse: Contract manufacturer 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.