Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008876063

FEI Number

3008876063

Entity Name

KITAZATO CORPORATION

City/State/Country

Fuji Shizuoka, JP

Establishment Address

100-10 Yanagishima, Fuji Shizuoka 416-0932, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Kitazato Corporation (Owner Number: 10045321)

Owner / Operator Contact Address

100-10 Yanagishima, Fuji, JP-22 416-0932, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140072

PMA Number

N/A

All Registered Proprietary Names

CryotopCL Kitazato OPU Needle with Connection Tube (model number Type2) Kitazato OPU Reduced Needle (model number Type3) Kitazato OPU Two-Stage Reduced Needle (model number Type4) Catheter 3Fr or 4Fr and Guide with Obturator Catheter 3Fr or 4Fr and Guide Stylet for Guide 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 KITAZATO VACUUM LINE Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 10 cm, model number Type 4-v3 and Type 4-v4 Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 18 cm, model number Type 5-v1 and Type 5-v2 Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 10 cm, model number Type 5-v3 and Type 5-v4 Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 18 cm, model number Type 4-v1 and Type 4-v2 Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1 Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2 CryotopUS Cryotop Vitrification Kit and Cryotop Thawing Kit SepaSperm Washing Solution SepaSperm Solution Kitazato OPU Reduced Needle, model number Type 3 Kitazato OPU Needle with Connection Tube, model number Type 2 Sperm Fridge Sperm Freeze Micro Tools Hypure Oil Hypure oil Single Step Culture Medium Sigle Step Culture Medium with rHA Single Step Culture Medium with HAS CryotopSC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2013-11-05
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2017-11-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2025-08-28
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2020-05-11
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-11-05
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2026-03-11
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2017-11-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2018-01-26
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2018-01-26
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-11-05
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2016-03-28
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2016-11-02
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2016-11-02
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2019-12-13
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2013-11-05
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-09-09
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2017-11-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2016-08-10
QKI	Media, Reproductive, Exempt	Obstetrics/Gynecology	Class 2	884.6180	2023-11-06
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-09-09
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2014-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Kitazato Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008456389	Kitazato Corporation	Minato-ku Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008876063. Last updated year: 2026. Please use registration number 3008876063 when referencing this establishment in official correspondence.