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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2025-07-09 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2013-10-28 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2017-08-09 |
| Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | OXF | Class 2 | General, Plastic Surgery | No | 2017-05-19 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2018-03-06 |
| Protective Coating, Mucoadhesive Application, For The Rectal Mucosa | PHN | Class U | Unknown | No | 2025-07-09 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2017-05-09 |
| Hemostatic Device For Endoscopic Gastrointestinal Use | QAU | Class 2 | General, Plastic Surgery | No | 2022-03-22 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2013-02-04 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2012-10-30 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2017-03-22 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2024-08-23 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-19 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2013-10-28 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2013-10-28 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2013-10-28 |
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2017-05-19 |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2022-03-22 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2013-10-28 |
| Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside | QRR | Class 2 | Orthopedic | No | 2024-08-23 |
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)