# Opcom Inc. (contract manufacturer, New Taipei City, TW): 1 new FDA device listing, incl. cystoscope and accessories, flexible/rigid

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Opcom Inc. |
| Owner / operator | OPCOM Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | New Taipei City, TW |
| New listings | 1 |
| Devices | Cystoscope And Accessories, Flexible/Rigid |
| Product codes | FAJ |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology |
| Brand names | Uro-G HD Cystoscope and accessories, flexible/rigid |
| First new listing | 2026-09-20 |
| Latest new listing | 2026-09-20 |
| FDA registration number | 3000279801 |
| Registration expires | 2027-12-31 |

## 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.