FDA Registration Active 🇧🇪 Belgium

Sterigenics Belgium Fleurus SA

Reg #: 3004681519 · FEI: 3003870583 · Expires 2026
Products
20
Proprietary Names
146
Establishment Types
1
Classifications
20

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Registration Details

Registration Name
Sterigenics Belgium Fleurus SA
Registration Number
3004681519
FEI Number
3003870583
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Zoning Industrial de Fleurus, Avenue De L Esperance, 17
City
Fleurus Hainaut
Country
BE

Owner / Operator

Firm Name
Sotera Health LLC
Operator Number
10029425
Address
2015 Spring Road, Suite 650
City
Oak Brook
State
IL
Postal Code
60523
Country
US
Correspondent
Karen Whaley-Krumins

Products

Device Name Product Code
Tonometer, Manual HKY
Mesh, Surgical FTM
Tonometer, Ac-Powered HKX
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery OXF
Dressing, Wound, Drug FRO
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa PHN
Filler, Bone Void, Calcium Compound MQV
Hemostatic Device For Endoscopic Gastrointestinal Use QAU
Dressing, Wound, Hydrophilic NAC
Negative Pressure Wound Therapy Powered Suction Pump OMP
Labware, Assisted Reproduction MQK
Bone Grafting Material, Synthetic LYC
Dressing, Wound, Occlusive NAD
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
Dura Substitute GXQ
Polymer, Ear, Nose And Throat, Synthetic, Absorbable NHB
Barrier, Animal Source, Intraoral NPL
Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside QRR

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 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 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 Probes for HOME, TP022

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)