FDA.reportPublic FDA data

OPCOM MEDICAL INC.

Matched from indexed company URL: Opcom Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30330108583033010858OPCOM MEDICAL INC.1N2026-01-0112F, 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 table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3282831502865216K242699Flexible 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)FGB2025-05-28
3282831419701300
3282831501232854
3282831545034789
3282831614849902
3282831836476767
3282832006774452
3282832053008662

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGB12025-05-28