# Okamoto Industries, Inc. (contract manufacturer, Ryugasaki-Shi, Ibaraki-Pref, JP): 3 new FDA device listings, incl. condom

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Okamoto Industries, Inc. |
| Role | Contract manufacturer |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Ryugasaki-Shi, Ibaraki-Pref, JP |
| New listings | 3 |
| Devices | Condom; Condom, Synthetic |
| Product codes | HIS, MOL |
| Device classes | Class II |
| Medical specialties | Obstetrics/Gynecology |
| Brand names | 04 HA |
| First new listing | 2026-08-24 |
| Latest new listing | 2026-09-18 |
| FDA registration number | 3006122980 |
| 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.