Data / Medical devices / Taiwan / Opcom Medical Inc.
Opcom Medical Inc.: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
Opcom Medical Inc. is registered with the FDA (registration 3033010858) in New Taipei City, Taiwan. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033010858
- Address
- 12F, No.6, JianKang Rd., Zhonghe Dist., New Taipei City 23586, Taiwan(R.O.C.), New Taipei City, Taiwan, 23586
- Owner or operator
- OPCOM Medical Inc. (10090696)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 30, 2024
- Registered through
- 2026
- Brand names listed
- Cystoscope And Accessories, Flexible/Rigid, Cystoscope and accessories, flexible/rigid, U-Scope, laryngoscope
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Non-Rigid | CAL | 1 | Contract manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Contract manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Contract manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 28, 2025 | K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | FGB | Substantially Equivalent | Opcom Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Laryngoscope, Rigid
- All makers of Laryngoscope, Non-Rigid
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Stylet, Tracheal Tube
Updated May 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.