Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611680

FEI Number

3002807969

Entity Name

RADIA INDUSTRY CO., LTD.

City/State/Country

Takasaki Gunma, JP

Establishment Address

168 Ooyagi, Takasaki Gunma 370-0072, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Radia Industry Co., Ltd. (Owner Number: 10042849)

Owner / Operator Contact Address

168 Ooyagi, Takasaki, JP-10 370-0072, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Steriject Sterijekt PENTAX Single Use Balloon OF-A67 PENTAX Single Use Balloon OE-A51 Safeshield Microscalpel Microscalpel with plastic handle AS-8313ASB ASB clear corn ang blade, 2.2mm (6/box) AS-8316ASB ASB clear corn ang blade, 2.5mm (6/box) AS-8324ASB ASB clear corn ang blade, 3mm (6/box) AS-8312ASB ASB clear corn ang blade, 2mm (6/box) AS-8318ASB ASB clear corn ang blade, 2.65mm (6/box) AS-8321ASB ASB clear corn ang blade, 2.8mm (6/box) Microscalpel with aluminum handle DISPOSABLE BIOPSY FORCEPS FB series FB-210U FB-215U FB-245U FB-225U FB-220K FB-221K FB-240U FB-230K FB-240K FB-241K FB-230U FB-211K FB-220U FB-235U FB-231K Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2 Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1 CryotopCL disposable lancet disposable lancet sp PENTAX Medical Single Use Balloon OE-A60 SINGLE USE BIOPSY VALVE SINGLE USE BIOPSY VALVE DISPOSABLE BIOPSY FORCEPS FB series PENTAX Medical Single Use Balloon OE-A61 HX-610-135S HX-610-090S HX-610-090L HX-610-135 HX-610-090 HX-610-135XS HX-610-135L SINGLE USE BIOPSY VALVE ROTATABLE CLIP FIXING DEVICE HX series Maeda New NeedleDisposable DISPOSABLE SCALPEL NO.10 DISPOSABLE SCALPEL NO.15 DISPOSABLE SCALPEL NO.11 disposable scalpel disposable scalpel mini disposable dermatome safeshield scalpel vessel disposable scalpel deep DISPOSABLE SCALPEL NO.12 DISPOSABLE SCALPEL NO.22 PENTAX Single Use Balloon OE-A56 DISPOSABLE HOT BIOPSY FORCEPS FD series MAJ-2315 CARBON STEEL BLADE NO.22 surgical blade stainless steel STAINLESS STEEL BLADE NO.25 STAINLESS STEEL BLADE NO.15 microsurgical blade for fine incision CARBON STEEL BLADE NO.12 BLADE, SCALPEL STAINLESS STEEL BLADE NO.12 skin graft knife blade, dermatome blade CARBON STEEL BLADE NO.23 CARBON STEEL BLADE NO.10 CARBON STEEL BLADE NO.11 STAINLESS STEEL BLADE NO.11 STAINLESS STEEL BLADE NO.23 STAINLESS STEEL BLADE NO.15C surgical blade carbon steel dissecting blade CARBON STEEL BLADE NO.25 STAINLESS STEEL BLADE NO.10 STAINLESS STEEL BLADE NO.12B CARBON STEEL BLADE NO.21 CARBON STEEL BLADE NO.15C CARBON STEEL BLADE NO.15 CARBON STEEL BLADE NO.12B STAINLESS STEEL BLADE NO.21 STAINLESS STEEL BLADE NO.22 STAINLESS STEEL BLADE NO.20 CARBON STEEL BLADE NO.20 CryotopUS SHORT HANDLED BIOPSY PUNCH 4MM SHORT HANDLED BIOPSY PUNCH 3.5MM SHORT HANDLED BIOPSY PUNCH 6MM SHORT HANDLED BIOPSY PUNCH 5MM Kitazato OPU Needle with Connection Tube, model number Type 2 Kitazato OPU Reduced Needle, model number Type 3 CryotopSC PENTAX Single Use Balloon OE-A52

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-02-01
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-03-10
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-03-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-03-10
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2013-01-07
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-04-11
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-12-05
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2013-12-05
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2013-01-07
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-03-10
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-01-07
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-01-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-03-10
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2024-06-25
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2013-01-07
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2013-01-07
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2013-01-07
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2013-01-07
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-03-10
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2013-01-07
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2024-04-11
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-04-11
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-01-07
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2016-03-24
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-07
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2013-12-05
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2016-03-28
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-03-10

Official Correspondent

Masako Tomita

US Agent Details

Takahiro Haruyama Business: Globizz Corp. Email: register@globizz.net Phone: (310) 5383860

Related Public Records

Same Entity

Radia Industry Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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 9611680. Last updated year: 2026. Please use registration number 9611680 when referencing this establishment in official correspondence.