FDA.reportPublic FDA data

OPTINA DIAGNOSTICS INC.

Matched from indexed company URL: Optina Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146068903014606890OPTINA DIAGNOSTICS INC.1N2026-01-018200 Decarie Blvd, Suite #220 Montreal Quebec CA H4P 2P5

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2925791954912909K250770Optina-4C (MHRC-C1N)HKI2025-09-04
2925791427048335K231230Optina-4C (MHRC-C1N)HKI2023-12-05
2925791350776083K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)HKI2020-04-27
2925791205062577

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HKI32025-09-04

PMN#