FDA device listing

Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, model number Type 2-v1,Kitazato IUI Catheter…

FDA device listing 1975127958 · Radia Industry Co., Ltd.

Key facts

Proprietary names Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, model number Type 2-v1,Kitazato IUI Catheter without Stainless Steel Center Core Type, 7 cm, model number Type 2-v2,Kitazato IUI Catheter with Stainless Steel Center Core Type, 10 cm, model number Type 1-v1,Kitazato IUI Catheter with Stainless Steel Center Core Type, 7 cm, model number Type 1-v2
Owner/operator Radia Industry Co., Ltd.
Owner/operator number 10042849
Product codes MQF
Device names MQF - Catheter, Assisted Reproduction
Device class Class II
Classification regulations (21 CFR) 884.6110
Review panels Obstetrics/Gynecology
Registered establishments RADIA INDUSTRY CO., LTD.
Establishment registrations 9611680
FEI numbers 3002807969
Establishment operations Contract Sterilizer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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