NIKKISO CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146382553014638255NIKKISO CO., LTD.1N2026-01-0120-3 EBISU 4-CHOME, SHIBUYA-KU Tokyo JP 150-6022

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3202082060209016K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)KOC2025-05-15
3202081189254950K231589Blood Tubing Lines for Hemodialysis AV06C-EKOC2023-07-28
3202081774396833K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesKOC2023-06-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KOC32025-05-15

PMN#