Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008132411

FEI Number

3008132411

Entity Name

Sterigenics Shanghai E Beam Ltd.

City/State/Country

Shanghai, CN

Establishment Address

A603 Lane 108, No. 588, Chuantu Road, ChuanSha, Pudong, Shanghai 201202, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Sotera Health LLC (Owner Number: 10029425)

Owner / Operator Contact Address

2015 Spring Road, Suite 650, Oak Brook, IL 60523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ArcScan Insight 100 ED3 EyeSeal AQUACEL Foam Super absorbent woven Eclypse Adherent Sacral Foam/silicone Advazorb Silflo/Silflo Lite Foam/silicone Advazorb/Advazorb Lite (Advazorb Plus) Super absorbent woven dressing Eclypse Boot Woven Eclypse Woven Ecylpse Adherent Mepore Pro / Ultra Foam/silicone Advazorb Silfix/Silfix Lite Non woven ribbon dressing Advadraw Spiral Non woven dressing Advadraw Dressing, Wound Hydrophilie Triad Foam Wound Dressings - 004766,004781,004782,003900, 003901,003902,003903,003904, 001502,001042, 005085 Zetuvit (plus) Advazorb Fixation Advadraw Zorflex ZF20 Zorflex ZF10 Eclypse Contour Zetuvit Plus Silicone (Border) Advazorb Heel Eclypse Adherent Advazorb Sacral Zorflex ZF15 Advazorb Areola Advadraw Spiral Advazorb Eclypse Foot Advazorb Silfix Eclypse Boot Eclypse Border & Border Oval Advazorb Border Lite Eclypse Advazorb Border Eclypse Adherent Sacral ConvaFoam Border ConvaFoam Non-Adhesive AQUACEL Foam Pro ConvaFoam Silicone Exufiber 07 0010 Samco Bio-Tite, 90mL, Midstream Kit with Funnel 02 0016 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap 02 0002 Cardinal Health Specimen Container, 90mL/48mm, ORG Cap container, specimen, sterile Vacuette No -Additive Tubes Clikseal Portex Speciman Trap Midstream Kit (Container Specimen) Pathology Container, Snap Cap, PN 0480-1101 Pathology Container, Snap Cap, PN 0450-1101 Pathology Container, Snap Cap, PN 0450-1111 1008/100 1002/36 Pathology Container, Snap Cap, PN 0501-1101 19227/12 B0810/50 Pathology Container, Snap Cap, PN 0480-1111 B0612/100 17531/50 B1708/50 TP002/50 1060/50 1050/50 PSS001/25 TP0014/50 B2923/50 B1212/25 17511/20 1005W/25 B1706/50 MHBFK01/10 JBQ773 1004/36 17531/20 PDC001/20 KB006L/20 B1111Z/25 B1912/100 B1710/100 1055/50 B1115Z/50 B0633/50 1013/100 1007/50 1070/50 SSB001/10 17555/50 B0606/25 BCP300/100 B0652/10 TP0015/50 17511C/20 TP0016/50 TP003/200 1001R/36 1055/75 SJMC001/10 B1215/100 Catch Kit: 25000 Speciman Cup: 8889207026 Corning Cryogenic vials and accessories Speciman Collection: 2600SA Catch Kit: 22000 Speciman Collection: 2090SA 430490 430661 430489 Speciman Container: 15000 Speciman Collection: 2205SA 431422 Speciman Collection: 2040SA Catch Kit: 22015 430663 430658 Speciman Collection: 2300SA Catch Kit: 25015 Speciman Collection: 2210SA 430659 430179 352001 Speciman Cup: 8889207067 Speciman Collection: 4090SA Speciman Container: 45117 Speciman Collection: 17099 Speciman Collection: 2200SA 352045 352006 Speciman Container: 14999 Speciman Container: 14000 431421 354015 Speciman Collection: 2650SA 352003 430488 Vitronova 431386 430487 430491 431418 430656 352037 431458 430492 354013 431420 431417 431419 430662 90ORG53-1001 90ORG53-1000 90WHT53-1000 SAMCO 90mL/53mm CLK SPC LBL WT CAP ST 5000-0020 Nalgene Cryogenic Tube, 2 mL externally-threaded 5005-0015 Nalgene Specimen Cryogenic Vial, 15 mL externally-threaded 02 1090 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, ORG Cap 90WHT53-1001 Samco Clicktainer Vial, WHT Cap, 90mL, 53mm, w/lab, temp strip, ST 90ORG53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, ORG Cap 07 0002 Samco Bio-Tite, ST, 120mL, 53mm Midstream Kit No Funnel 03 0006 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, ORG Cap 07 0001 Samco Bio-Tite, ST, 90mL, 48mm Midstream Kit with Funnel 22-2090 Samco Bio-Tite Wide Mouth, ST, 90mL, 53mm, w/lab, YEL Cap 02 1016 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, WHT Cap 120WHT53-3000 Samco Clicktainer Vials, ST, 120mL, 53mm, Midstream Kit, no fnl 01 0001 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, ORG Cap CHB13905 Cardinal HealthTM Specimen Container, O/R Pouch 120mL/53mm 120ORG53-1000 Samco Clicktainer Vials, ST, 120mL, 53mm, w/lab, ORG Cap 90ORG53-1001 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, ORG Cap, dsp box 5005-0015 Nalgene Specimen Cryogenic Vial, 15 mL externally-threaded 02 0002 Cardinal HealthTM Specimen Container, 90mL/48mm, ORG Cap 01 0002 120ml/53mm SPCw/LBL, WH CAP,ST 02 0039 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, WHT Cap 120ORG53-4000 Samco Clicktainer Vials, ST, 120mL, 53mm, O/R Pouch, ORG Cap 02 1038 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap 02 0214 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box CHB13904 Cardinal HealthTM Specimen Container 120mL/53mm 90WHT53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, WHT Cap 120ORG53-4000 22 610 131 Fisherbrand 60mL, 48mm, ST, w/lab and temp strip, WHT Cap 120WHT53-4000 03 0008 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, Green Cap 07 0020 Samco Bio-Tite, 120ml, Midstream Kit, no funnel CHB13903 Cardinal HealthTM Specimen Container 90mL/53mm 5000-0050 Nalgene Cryogenic Tube, 5 mL externally-threaded 01 0038 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap CHB13902 Cardinal HealthTM Specimen Container 90mL/48mm 120WHT53-1000 Samco Clicktainer Vials, ST, 120mL, 53mm, w/lab, WHT Cap 07 0000 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, no lab, ORG Cap 90WHT53-1002 Samco Clicktainer Vial, ST, 90mL, 53mm, w/temp strip, WHT Cap 90GRN53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, GRN Cap 03 0007 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, WHT Cap 02 0038 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, Natural Cap 120WHT53-4000 Samco Clicktainer Vials, ST, 120mL, 53mm, O/R Pouch, WHT Cap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2023-08-04
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2023-08-24
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2023-08-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-07-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-07-13
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-02-04
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2010-06-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-07-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-07-30
PKP	Immunoglobulin G (Igg) Infusion System	General Hospital	Class 2	880.5725	2025-07-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-07-30
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2017-03-21

Official Correspondent

Karen Whaley-Krumins

US Agent Details

Chris Eustace Email: ceustace@sterigenics.com Phone: (630) 9281700

Related Public Records

Same Entity

Sotera Health LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005914490	UNIDADE DE ESTERILIZACAO COTIA LTDA.	Cotia Sao Paulo, BR
9680579	Sterigenics Radiation Technologies Canada, Inc	PORT COQUITLAM British Columbia, CA
9616517	Sterigenics S. de R.L. de C.V.	Tepeji del Rio de Ocampos Hidalgo, MX
3008328679	Sterigenics S. de R.L. de C.V.	Cuautitlan Izcalli Mexico, MX
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008132411. Last updated year: 2026. Please use registration number 3008132411 when referencing this establishment in official correspondence.