FDA.reportPublic FDA data

ROCAMED SAM

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30160960973016096097ROCAMED SAM1N2026-01-019 Avenue Albert II Le copori MONACO Monaco-Ville MC 98000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3345771792318414K260632LASER THERMAL THERAPY KITGEX2026-03-17
3345772005398557K230460Laser Thermal Therapy KitGEX2023-05-22
3345771983368463K213594ECHOLASER X4GEX2022-05-03
3345771249963408K212868JFil Ureteral Stents, JFil Ureteral Stents ECO KITFAD2022-01-26
3345771981010585K192183RocaTub Ureteral CatheterEYB2020-04-23
3345771881630821K182144Bi-Flex EvoKNY2018-09-07
3345771640641814K173734RocaJJ Soft StentsFAD2018-03-12
3345771222156770K152278ENDOFLOW II - Irrigation, Warming and Suction SystemOCX2016-02-09
3345771320210099
3345771451344492
3345771536892394
3345771728582219
3345771785026673

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX32026-03-17
FAD22022-01-26
EYB12020-04-23
KNY12018-09-07
OCX12016-02-09

PMN#