Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015136743

FEI Number

3015136743

Entity Name

STERI-TECH CO.,LTD.

City/State/Country

KAZO-SHI Saitama, JP

Establishment Address

5-13-1 HANASAKI, KAZO-SHI Saitama 347-0032, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Steri-Tech Co.,Ltd. (Owner Number: 10059220)

Owner / Operator Contact Address

5-13-1 HANASAKI, KAZO-SHI, JP-11 347-0032, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Distal Cap Model DH-17EN2 Distal Cap Model DH-32EN "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B30-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N30-" "Fujifilm Diathermic Slitter (ClutchCutter) models DP2618DT -50-" "Fujifilm Diathermic Slitter (ClutchCutter) models DP2618DT -35-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N25-" Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N10- "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -N20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B25-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -N15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -B20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -B15-" Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B25- Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B20- FUJIFILM Over-tube TS-1214C "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -N20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N25-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -B15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -B20-" Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N10- "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N30-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N20-" "Fujifilm Diathermic Slitter (ClutchCutter) models DP2618DT -35-" Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B25- "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B30-" Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B20- "Fujifilm Diathermic Slitter (ClutchCutter) models DP2618DT -50-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -N15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B25-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B20-" FUJIFILM Hood Models DH-30CR FUJIFILM Hood Models DH-28GR FUJIFILM Hood Models DH-29CR DH-083ST Catheter 3Fr or 4Fr and Guide with Obturator Catheter 3Fr or 4Fr Stylet for Guide Catheter 3Fr or 4Fr and Guide SEIRIN PY Zero SEIRIN Shonishin "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B25-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N25-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -N15-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -B15-" Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N10- "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -N20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -B20-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B30-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N30-" "Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B15-" Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B20- Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B25- SB-602 Suction Button for 530 Series Bronchoscopes (Sterile) FUJIFILM Over-tube TR-1504A FUJIFILM Over-tube TR-1507A TR-1108A Catheter 4.7Fr Supported (EC-PRO Supported) Echogenic Trial Catheter 4.7Fr Supported (Trial EC-PRO Master Supported) ); Echogenic Catheter 4.7Fr(EC-PRO Master) Stylet for Guide (EC-PRO Stylet) KITAZATO ET Catheters; Catheters 4.7Fr(EC-PRO) Echogenic Catheter 4.7Fr Supported (EC-PRO Master Supported) Trial Catheter 4.7Fr (Trial EC-PRO) Trial Catheter 4.7Fr Supported (Trial EC-PRO Supported) Echogenic Trial Catheter 4.7Fr(Trial EC-PRO Master) Single Use Suction Valve SB-606 Single Use Forceps Valve FV-003 Sterile Overtube models TS-13140 Sterile Overtube models TS-13101 Sterile Overtube models TS-12140 Kitazato OPU Reduced Needle (model number Type3) Kitazato OPU Two-Stage Reduced Needle (model number Type4) Kitazato OPU Needle with Connection Tube (model number Type2) B20BU Balloon for EB-530US Balloon BS-3 Distal Cap Models DH-34CR Distal Cap Models DH-38CZ Distal Cap Models DH-33GR Distal Cap Models DH-37CZ Distal Cap Models DH-35GZ Distal Cap Models DH-40GR Distal Cap Models DH-39CZ Pyonex Seirin Pyonex Needles G-Type J-15 B-Type M-Type D-Type Spinex Intradermal J ProPak10 J-Type KB-Type L-Type ELIPEAS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-12
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-12
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2019-12-06
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2025-03-28
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2018-12-12
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2018-12-12
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2019-12-06
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-12-06
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-12-06
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2018-12-12
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-12-28
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2022-01-12
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2020-12-17
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2019-12-06
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2018-12-17
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-12-28
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-12-17
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2018-12-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-12-09
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-12-06
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2018-12-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-01-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-01-12
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2022-01-12
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-12
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-12
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2020-12-17

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

Steri-Tech Co.,Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018159925	West Sterilization factory	Kobe-Shi Hyogo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01
K904800	Olympus Corp.	SIF-SW	1991-03-27
K233321	FUJIFILM Healthcare Americas Corporation	Double Balloon Endoscope EN-840T, Over-tube TS-1214C	2024-06-13
K251204	FUJIFILM Healthcare Americas Corporation	FUJIFILM Stiffening Wire Device (SW-2000)	2025-09-26
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015136743. Last updated year: 2026. Please use registration number 3015136743 when referencing this establishment in official correspondence.