# Drtech Corporation (contract manufacturer, Seongnam-si Gyeonggi, KR): 1 new FDA device listing, incl. system, x-ray, stationary

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Drtech Corporation |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Seongnam-si Gyeonggi, KR |
| New listings | 1 |
| Devices | System, X-Ray, Stationary |
| Product codes | KPR |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | GC85A with Prestige; AccE GC85A; GC85A |
| First new listing | 2026-09-16 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 3024891354 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.

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.