Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004681519

FEI Number

3003870583

Entity Name

Sterigenics Belgium Fleurus SA

City/State/Country

Fleurus Hainaut, BE

Establishment Address

Zoning Industrial de Fleurus, Avenue De L Esperance, 17, Fleurus Hainaut B-6220, BE

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

iCare TP022 Probes iCare TP01s Probes Tutoplast® porcine dermis Fortiva¿ porcine dermis Tutopatch® Bovine Pericardium Tutomesh® Bovine Pericardium Icare Tonometer Probes, TP01s CERAMENT BONE VOID FILLER iCare TP01s Probes 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 VAC WhiteFoam Large Dressing w/ SensaTRAC VAC WhiteFoam Small Dressing w/ SensaTRAC VAC WhiteFoam Large Dressing (foam only) VAC WhiteFoam Small Dressing (foam only) ActiVAC, 5 Pack KCI VAC GRANUFOAM LARGE BRIDGE DRESSING 5 PACK ASSY, 10 PACK V.A.C. 3M TEGADERM DRAPE Culture Dish 40 mm 5 Well Culture Dish Micro Droplet Culture Dish ICSI Dish Centre Well Dish Straumann BoneCeramic ALLEVYN Complete Care 3"x4" Primapad Non-Adherent Dressing 3"x8" Primapad Non-Adherent Dressing Biatain CUD Film Wound Dressing Silflex DUODERM STERILE DRESSING, DUODERM STERILE DRESSING (SIGNAL HYDROACTIVE), BORDER, CG, EXTRA THIN, 2"x3" Reliamed Non-Adherent Dressing Episil Absorbent DUODERM CGF BDR DRS 15X15CM (1X5PK) NAI DUODERM CGF DRS15X20CM (1X5PK) NAI DUODERM SIGNAL 20X20CM (1X5PK) NAI DUODERM SIGNAL 15X18CM (1X5PK) NAI DUODERM XTHIN DRS OVAL (1X20PK) NAI DUODERM CGF BDR DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X20CM (1X5PK) NAI DUODERM SIGNAL 20X22.5CM (1X5PK) NAI DUODERM SIGNAL 14X14CM (1X5PK) NAI DUODERM SIGNAL 20X23CM (1X5PK) NAI DUODERM XTHIN DRS TRG (1X10PK) NAI DUODERM SIGNAL 18.5X19.5CM (1X5PK) NAI Bolin Chest Seal DUODERM XTHIN DRS 10X10CM (1X10PK) NAI DUODERM CGF BDR DRS 6X6CM (1X5PK) NAI DUODERM CGF DRS 15X15CM (1X20PK) NAI DUODERM XTHIN DRS 5X20CM (1X10PK) NAI DUODERM XTHIN DRS OVAL (1X10PK) NAI DUODERM SIGNAL 11X19CM (1X5PK) NAI DUODERM XTHIN DRS 7.5X7.5CM (1X20PK) NAI DUODERM CGF DRS 15X15CM (1X5PK) NAI DUODERM CGF BDR DRS 10X13CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X30CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X20PK) NAI DUODERM CGF BDR DRS 15X18CM (1X5PK) NAI DUODERM XTHIN DRS 5X10CM (1X20PK) NAI DUODERM SIGNAL 10X10CM (1X5PK) NAI DUODERM XTHIN DRS 15X15CM (1X10PK) NAI DUODERM DRS 10X10CM (1X20PK) NAI Biatain Silicone ALLEVYN Gentle Stratamed StrataXRT Biatain Silicone Lite Stratacel Allevyn Life H-Vent StrataGRT NelDerm Hydrogel Dressings Derpixa StrataCTX Comfeel Plus Biatain Super Non-Adhesive Band-Aid Neutrogena Sensitive Skin Triangle Acne Patches Comfeel Plus Contour Biatain Super Adhesive Adhesive Bandage Coverlet Biatain Silicone Non-border Neutrogena Sensitive Skin Mini Acne Patches Comfeel Plus Transparent Foam Lite ConvaTec Neutrogena Sensitive Skin Blemish Patches Episil Biatain Adhesive CUD+ CTD Dressing wound occlusive Biatain Soft-Hold 2"x3" Primapad Non-Adherent Dressing Biatain Non-Adhesive Neutrogena Sensitive Skin Nose Patches Hydrocolloid adhesive bandages Compeed Neutrogena Stubborn Acne Ultra-Thin Blemish Patches Biatain Silicone Fit CERAMENT BONE VOID FILLER InfoVAC with Gel, 10 Pack InfoVAC without Gel, 10 Pack INFOVAC CAN ASSY, W/O GEL, 5 PK INFOVAC CAN ASSY, W/ GEL, 10 PK INFOVAC CAN ASSY, W/O GEL, 10 PK V.A.C. WhiteFoam Dressings Tutopatch® Bovine Pericardium

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2025-07-09
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-10-28
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-10-28
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2017-08-09
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2017-08-09
OXF	Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2017-05-19
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2017-05-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-03-06
PHN	Protective Coating, Mucoadhesive Application, For The Rectal Mucosa	Unknown	Class U	N/A	2025-07-09
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2017-05-09
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2025-07-09
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2025-07-09
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	General, Plastic Surgery	Class 2	878.4456	2022-03-22
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-02-04
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2012-10-30
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2017-03-22
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2024-08-23
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-12-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-12-08
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-12-08
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	General, Plastic Surgery	Class 2	878.4456	2025-07-09
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2013-10-28
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2013-10-28
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-10-28
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2013-10-28
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2012-10-30
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2017-05-19
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2013-10-28
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-10-28
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2013-10-28
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2013-10-28
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2022-03-22

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
3008132411	Sterigenics Shanghai E Beam Ltd.	Shanghai, CN
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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K870750	Keeler Instruments, Inc.	KEELER PULSAIR NON CONTACT TONOMETER	1987-03-17
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0036-2025	Wilson-Cook Medical Inc.	2	Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004681519. Last updated year: 2026. Please use registration number 3004681519 when referencing this establishment in official correspondence.