OPCOM MEDICAL INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3033010858 | 3033010858 | OPCOM MEDICAL INC. | 1 | N | 2026-01-01 | 12F, No.6, JianKang Rd., Zhonghe Dist., New Taipei City 23586, T New Taipei City TW 23586 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 328283 | 1502865216 | 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 | 2025-05-28 |
| 328283 | 1419701300 | ||||
| 328283 | 1501232854 | ||||
| 328283 | 1545034789 | ||||
| 328283 | 1614849902 | ||||
| 328283 | 1836476767 | ||||
| 328283 | 2006774452 | ||||
| 328283 | 2053008662 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FGB | 1 | 2025-05-28 |