# Endorobotics Co., Ltd. (manufacturer, Seoul, KR): 3 new FDA device listings, incl. colonoscope and accessories, flexible/rigid

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Endorobotics Co., Ltd. |
| Owner / operator | EndoRobotics Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Seoul, KR |
| New listings | 3 |
| Devices | Colonoscope And Accessories, Flexible/Rigid; System, Surgical, Computer Controlled Instrument; Gastroscope And Accessories, Flexible/Rigid |
| Product codes | FDF, NAY, FDS |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology |
| Brand names | R-Power Cable (North America) (PC-R-002); Controller A (R-JA-002); ROBOPERA™ Accessories (R-AC-001); Controller B (R-JB-002); ROBOPERA™ Storage Case (RPSC-001); ROBOPERA (ER-R-002); ROBOPERA™ Set (ER-RS-002); ROBOPERA (ER-R-003) |
| First new listing | 2026-07-13 |
| Latest new listing | 2026-07-13 |
| FDA registration number | 3044545674 |
| Registration expires | 2026-12-31 |

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