FDA Registration Active 🇫🇷 France

Sterigenics SAS

Reg #: 3007156625 · FEI: 3008133910 · Expires 2026
Products
38
Proprietary Names
378
Establishment Types
1
Classifications
38

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Registration Details

Registration Name
Sterigenics SAS
Registration Number
3007156625
FEI Number
3008133910
Status
Active
Expiry Year
2026
Initial Importer
No
Address
8 Rue Parmentier
City
Rantigny Oise
Country
FR

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
Shunt, Central Nervous System And Components JXG
Mesh, Surgical, Polymeric FTL
Dislodger, Stone, Basket, Ureteral, Metal FFL
Laparoscope, Gynecologic (And Accessories) HET
Hysteroscope (And Accessories) HIH
Culdoscope (And Accessories) HEW
Device, Monitoring, Intracranial Pressure GWM
Implant, Endosseous, Root-Form DZE
Catheter, Retention Type, Balloon EZL
Endoscopic Access Overtube, Gastroenterology-Urology FED
Catheter, Nephrostomy LJE
Stent, Ureteral FAD
Port & Catheter, Implanted, Subcutaneous, Intraventricular LKG
Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
Electrode, Cortical GYC
Powered Laser Surgical Instrument GEX
Instrument, Shunt System Implantation GYK
Catheter, Ureteral, Gastro-Urology EYB
Filter, Intravascular, Cardiovascular DTK
Syringe, Cartridge EJI
Stimulator, Nerve ETN
Dilator, Catheter, Ureteral EZN
Catheter, Continuous Flush KRA
Endoscopic Guidewire, Gastroenterology-Urology OCY
Mesh, Surgical, Deployment Balloon OQL
Catheter, Nephrostomy, General & Plastic Surgery GBO
Neurosurgical Nerve Locator PDQ
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
Lavage, Jet FQH
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Needle, Dental DZM
Needle, Biopsy, Cardiovascular DWO
Stylet, Surgical, General & Plastic Surgery GAH
Endoscopic Injection Needle, Gastroenterology-Urology FBK
Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
Guide, Surgical, Instrument FZX
Curette, Suction, Endometrial (And Accessories) HHK
Instrument, Surgical, Non-Powered HAO

Proprietary Names

Subdural Drainage Catheter Kit Parietex™ ProGrip™ DORMIA Fertiloscopy F42K Kit FH 1.29 / FTO 1.40. Intracranial Pressure Monitoring Cup Catheter (ICP) Celsite® Discreet STL201H Integra Flow Regulating Valves Low Flow Integra Flow Regulating Valves Low Flow Mini Integra OSV II Valve Units OSV ll Valve SYstem 2 PIECE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem WITH ANTECHAMBER AND INTEGRAL 7 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Low Pro Valve System 3 PIECES SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Low Pro Valve System with antechamber and separate 15 cm ventricular catheter FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem BURR HOLE SYSTEM FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem 3 PIECE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Lumbar Valve System FLOW REGULATION* : 18 - 30 ml/hr WITH SEPARATE 80 CM LUMBAR CATHETER OSV ll Valve SYstem FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve Unit WITH 2 INTEGRAL CONNECTORS FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System with separate 15 cm ventricular catheter FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH ANTECHAMBER AND INTEGRAL 13CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH ANTECHAMBER AND INTEGRAL 9 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH INTEGRAL 9CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System 3 PIECES SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem BURR HOLE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Low Pro Valve Unit WITH ANTECHAMBER AND 2 INTEGRAL CONNECTORS FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem WITH INTEGRAL 7 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr lntegra Flow Regulating Valve Low Flow Std FLOW REG : 8 - 17 MI/hr 3 PIECES SYSTEM WITH ANTECHAMBER Folysil Silicone Foley Catheter Re-Trace Ureteral Access Sheath L22&55cm Integral Drainage Set Integral Lumbar Drainage Set Integral Ventricular Drainage Set Kolibri Direct Puncture Sets Kolibri Percutaneous Nephrostomy Catheters Kolibri Percutaneous Nephrostomy Kits CSF Reservoir Celsite Babyport (REF 05433742) / Celsite Babyport S (REF 05433842) Slotted Catheter Reservoir 4cm Phoenix Slotted Right Angle ca Slotted Catheter Reservoir 8cm Neonatal Reservoir - 7cm Anti-Block Catheter 12cm Scope Anti-Block Catheter 7cm Scopea Endoscopic right angle, Anti-Blok ventricular catheter with reservoir, 3 cm Anti-Block Catheter 8cm Scopea Phoenix Slotted Catheter Slotted Right Angle Catheter 9 Neonatal Reservoir - 6cm Slotted Catheter Reservoir 9cm Anti-Block Catheter 10cm Scope Anti-Block Catheter 6cm Scopea Slotted Right Angle Catheter 5 Anti-Block Catheter 4cm Scopea Neonatal Catheter Reservoir 4c Phoenix Slotted Cathter Reserv Anti-Block Catheter 11cm Scope Neonatal catheter reservoir 3c Slotted Right Angle Catheter 6 Neonatal Reservoir - 5cm Slotted Catheter Reservoir 6cm Slotted Catheter Reservoir 10c Slotted Catheter Reservoir 12c Anti-Block Catheter 9cm Scopea Slotted right angle catheter 7 Slotted Catheter Reservoir 7cm Anti-Block Catheter 5cm Scopea Slotted Catheter Reservoir 11c Slotted Right Angle Catheter 8 Auragen Cortical electrode Auragen Cortical surface electrodes OSYHAND LIPO Tubular Sheath Catheter Passer Re-Trace Ureteral Access Sheath Ureteric catheters RUP Right Angle Guide Smoothkit SMOOTHKIT+ Celsite (REF 05433734) Polypropylene Burr-hole Reservoirs and Cap Infusion Catheter 30cm with Mo Infusor Infusion Tubing VenaTech LGM 30D/U Vortek Double Loop Ureteral stents Parietene Macroporous Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 7 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 6 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 5 cm Perf (Ommaya Style) Reservoir Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 12 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 11 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 3 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 10 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 9 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 4 cm Perf (Ommaya Style) Reservoir, bottom-inlet, 19 mm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 8 cm Pressio® Parenchymal Bolt Intracranial Pressure Monitoring Kit Pressio® Parenchymal Tunneling Intracranial Pressure Monitoring Kit Pressio® disposable hand drill Ventricular Tunneling ICP Monitoring Pressio® Kit CABSAIR® PEDIGUARD PediGuard TriTip 2.5 XS PediGuard XS PediGuard Tri-Tip 3.2 PediGuard Tri-Tip 4 PediGuard Curv PediGuard Curv XS PediGuard Cannulated Handle PCN and Ureteral Dilators Magic Catheter Integra Ventricular Catheters with radiopaque dots Kubula External Drainage Catheter Integra DP Valve System Integra DP Valve Systems, stainless steel connectors, burr hole reservoirs and caps Ventricular, atrial and peritoneal catheters Subcutaneous Tube Passer Connector PTFE-coated Seldinger guidewire PCN guidewires Soprano® PTFE-Nitinol Guidewire BIOMESH® CA.B.S.' AIR® Composite Burr Hole Valve and Shunt System DSG Pin Total Abscession Nephrostomy Drainage Catheter GP General Purpose Drainage Catheter Aspiration and Flush Assembly Skater Nephrostomy Drainage Catheter w/ Locking Pigtail Ulti-Flo General Purpose Drainage Catheter Nephro-Cath Nephrostomy Drainage Catheter ReSove CirQ Nephrostomy Catheter PCN Needles Omnishunt Valve System Gravity Compensating Accessory DSG Pin 6 DSG Pin 1 DSG Pin 5 ARIS 4DDOME® Disposable Catheter Passer 30c Disposable Catheter Passer 65c Disposable Catheter Passer 45c Celsite (REF 05430095, 05430425, 05432460, 05433556, 05433750, 05433823, 05436709, 05436717, 05436725, 05436946) Celsite Discreet (REF 05430144, 05430145, 05430146) NovoFlow Reinforced Ureteral Stent External Drainage Set Lumbar drainage sets and accessories Tuohy needles Lumbar Catheter Accessory Kit Complete ICP Monitoring and Drainage Set 14G TUOHY NEEDLE Equi-Flow Valve and Shunt Systems Right Angle Step Connector Neonatal straight connector "Y" Connector Straight Connector 5/pack "T" Connector POWERPULSE HIP/KNEE DISP UNT W/SUCT POWERPLSE HIP/KNEE DISP UNT W/O SUC 0210-166-000 0210-210-000 0210-010-100S1 0211-110-000 0210-015-000 0210-218-000 0210-010-100 0210-918-100 0210-114-100 0210-918-000 0210-018-200 0211-100-000 0210-167-000 0210-218-100 0210-118-100 0211-214-000 0210-018-100 0210-018-000 0210-012-000 0211-118-000 0210-165-000 0210-114-100S1 0210-014-000 0210-200-000 0210-114-000S5 0210-212-000 0210-100-000 0211-112-000 0210-158-000 0210-118-200 0210-100-000S4 0210-110-000 0210-016-000 0210-112-000 0210-014-100 0211-212-000 0210-114-000 0210-058-000 0210-900-000 0210-214-000 0211-114-000 0210-010-000 0210-110-100 0210-118-000 0210-014-600 ELEFANT Bio Med wash Drainage Accessory Kit Silicone Double Loop Ureteral Stent Stent, Ureteral Silicone Double Loop Ureteral Stent Jackson-Pratt Wound Drainage Devices TRU-CLOSE Suction Drainage System Suction Reservoir Kit Celsite Concept (REF 05437025, 05437026, 05437028) Celsite (REF 05430100, 05430101) SimpleCAP™ X-TIP Biopsy Needles M-Biopsy™ Needle For Reusable Biopsy Instruments Bone Marrow Biopsy and Aspiration Needles Double Diamond "J" and "I" Type Bone Marrow Needle HV Lumbar Valve Systems and accessories HV Lumbar Valve Systems and Stainless Steel F5/ F8 Stepdown Connectors Rickham Type Reservoir Polysul Venatech LP Brachial Introducer System (Antecubital) (REF 04439985) PediGuard DSG Connect 3.2 PediGuard DSG Connect 4 PediGuard DSG Connect 2.5 XS PediGuard DSG Connect Curv Xs PediGuard DSG Connect Curv PediGuard DSG Connect 2.5 DSG Connect Handle DSG Starter Pin Endoscope and accessories Bone Needle for Bladder Injections Endoscope and accessories Bone Needle for Bladder Injections Integra Auragen Depth electrodes Integra NPH Low Flow Valve Cyst Puncture Catheter In-line CSF Reservoir , Double Dome / Catheter Right Angle Ventricular Catheter Res. / Pectoral 4 cm Anti-reflux Peritoneal Catheter Right Angle Ventricular Catheter Res. / Pectoral 11 cm Peritoneal Catheter Polypropylene 3-way Connector Right Angle Ventricular Catheter 5 cm Anti-reflux Atrial Catheter Right Angle Ventricular Catheter Reservoir 5 cm Right Angle Ventricular Catheter 6 cm Paediatric Straight Ventricular Catheter 1.3 x 2.2 Right Angle Ventricular Catheter Res. / Pectoral 10 cm Right Angle Ventricular Catheter Res. / Pectoral 9 cm Right Angle Ventricular Catheter Reservoir 6 cm Titanium Symmetrical Connector Right Angle Ventricular Catheter Reservoir 8 cm Convertible CSF Reservoir, Flat Bottom Large Model / Catheter Convertible CSF Reservoir, Burr Hole Small Model / Catheter Right Angle Ventricular Catheter 4 cm Standard CSF Reservoir, Flat Bottom Large Model / Catheter Right Angle Ventricular Catheter 9 cm Right Angle Ventricular Catheter 7 cm Right Angle Ventricular Catheter Res. / Pectoral 8 cm Convertible CSF Reservoir, Flat Bottom Small Model / Catheter Right Angle Ventricular Catheter Reservoir 7 cm Standard CSF Reservoir, Burr Hole Large Model / Catheter Graduated Straight Ventricular Catheter 1.3 x 2.2 Standard Straight Ventricular Catheter 1.3 x 2.5 Right Angle Ventricular Catheter 8 cm Right Angle Ventricular Catheter Res. / Pectoral 12 cm Right Angle Ventricular Catheter Res. / Pectoral 7 cm Right Angle Ventricular Catheter Reservoir 11 cm Right Angle Ventricular Catheter Res. / Pectoral 3 cm Right Angle Ventricular Catheter Reservoir 9 cm Right Angle Ventricular Catheter Reservoir 4 cm Right Angle Ventricular Catheter Res. / Pectoral 5 cm Right Angle Ventricular Catheter Reservoir 12 cm In-line CSF Reservoir , Single Dome / Catheter Right Angle Ventricular Catheter Reservoir 3 cm Side-Inlet CSF Reservoir, Flat Bottom Large Model / Catheter Convertible CSF Reservoir, Burr Hole Large Model / Catheter Straight Ventricular Catheter 1.5 x 3 Side-Inlet CSF Reservoir, Flat Bottom Small Model / Catheter Titanium Asymmetrical Connector Right Angle Ventricular Catheter Res. / Pectoral 6 cm Integra OSVII Low Pro Valve Systems Integra OSV II Valve Systems Vortek® Single Loop Ureteral Stent Suturable Tubing Clamps and Y-lumbar catheter Polypropylene connector Peritoneal Introducers Sheaths X-Flow Prostactectomy Catheter, Straight Catheter, Retention Type, balloon X-Flow Prostactectomy Catheter, Straight X-Flow prostactectomy Catheter Vortek Hydro Double Loop Ureteral stents Malleable Tunneler Ureteric catheters Floppy and Flush Venatech LP (REF 05010024) Guide Wire Insertion Device BowTie GABBAY-FRATER 1.3MM X 2.7MM DRILL GUIDE DTRAX Spinal System P-L VLP UNIV DRILL GDE HANDLE W PVT HD MEDTRONIC Facet Screw Instruments TRIPLE DRILL GUIDE Prostate Needle Guide KYPHON® Introducer Tool Kit THE SNAKE Zimmer Guide Pin Facet Screw Insruments Ad-Tech Sleeve Guides Wire Caddy Needle Guide Guide, surgical, instrument LAA Selection Guide POLARIS® SPV-400 ADJUST VALVE / ANTECHAMBER POLARIS® SPV-140 ADJUST VALVE / ANTECHAMBER POLARIS® VALVE / 5 PRESS. Low Operating Pressure POLARIS® SPV-300 ADJUST VALVE / ANTECHAMBER POLARIS® VALVE / 5 PRESS. High Operating Pressure Pediatric Right Angle ventricular catheter, Vision, 7 cm 6 " Open End Catheter Pediatric Right Angle ventricular catheter, Vision, 9 cm Open-Pliant Peritoneal Catheter Closed-Pliant Peritoneal Catheter, 90 cm Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit - V-TUN Biosoft duo Double Loop Ureteral stents Biomesh® P1 and Biomesh® Plug and Patch POLARIS® SPV ADJUST VALVE / ANTECHAMBER POLARIS® VALVE / 5 PRESS. POLARIS® SPV ADJUST. VALVE / BURR HOLE RES. POLARIS ® SPV KIT PREATTACHED/ BO19-10 POLARIS ® SPVA KIT PREATTACHED / BO19-10 Transducer for ICP Monitoring Set Polaris® Adjustable valve, 10-140 with SiphonX® SiphonX® Gravitational Anti-siphon Device Polaris® Adjustable valve, 10-140 with Antechamber and SiphonX® Polaris® Adjustable Valve, 30-200 with SiphonX® Polaris® Adjustable Valve, 30-200 with Burr Hole Reservoir and SiphonX® Polaris® Adjustable Valve, 30-200 with Antechamber and SiphonX® VenaTech Convertible (REF 05010028 ) PIPELLE® PIPELLE DE CORNIER MARK II PIPELLE DE CORNIER PIPELLE® MARK II SUPRIS Ventricular Catheter Accessory Kit IVMCS Straight Ventricular Drainage Catheter Right Angle Ventricular Catheters OSYFIBRE 600 OSV II Low Flow Lumbar Valve Integra Flow Regulating Valve Low Flow, Lumbar OSV II Lumbar Valve and Systems OSV ll Lumbar Valve System FLOW REGULATION* : 18 - 30 ml/hr WITH ANTECHAMBER AND SEPARATE 80 CM LUMBAR CATHETER OSV ll Valve System with antechamber and separate 15 cm ventricular catheter FLOW REGULATION* : 18 - 30 ml/hr Contour-Flex Valve and Shunt Systems and catheters Mini Perf Unitized Tapping Reservoir, 2 cm Anti-blok ventricular catheter Right-angle, neonatal Anti-blok ventricular catheter, 6 cm length, Vision tubing Mini Perf Unitized Tapping Reservoir, 5 cm Anti-blok ventricular catheter Right-angle, neonatal Anti-blok ventricular catheter, 8 cm length, Vision tubing Right-angle, neonatal Anti-blok ventricular catheter, 9 cm length, Vision tubing Mini Perf Unitized Tapping Reservoir, 2.5 cm Anti-blok ventricular catheter Right-angle, neonatal Anti-blok ventricular catheter, 3 cm length, Vision tubing Right-angle, neonatal Anti-blok ventricular catheter, 7 cm length, Vision tubing Right-angle, Spiral-Port ventricular catheter, 5 cm length Right-angle, neonatal Anti-blok ventricular catheter, 5 cm length, Vision tubing Silicone Hydro Double Loop Ureteral Stent Ventricular Antechambers PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL W/BOLT Integra NeuroBalloon Catheter KROLMAN INSTRUMENT Ad-Tech Obturators Wyler Transector NEUROBALLOON™ CATHETER

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)