# Aomori Olympus Co., Ltd. Hirosaki Site (repackager or relabeler, Hirosaki-shi Aomori, JP): 4 new FDA device listings, incl. forceps, biopsy, electric

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Aomori Olympus Co., Ltd. Hirosaki Site |
| Owner / operator | Olympus Corporation |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Hirosaki-shi Aomori, JP |
| New listings | 4 |
| Devices | Forceps, Biopsy, Electric; Gastroscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Hemostatic Metal Clip For The Gi Tract |
| Product codes | KGE, FDS, FAS, PKL |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology |
| Brand names | FD-412LR; FD-411UR; D-201-13404; SD-230U-20; HX-610-135XS; HX-610-135S; HX-610-135; HX-610-090L |
| First new listing | 2026-06-16 |
| Latest new listing | 2026-09-01 |
| FDA registration number | 3014769442 |
| Registration expires | 2027-12-31 |

## Why this score
- 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: 2026-11-04T21:52:36.524Z.
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.