FDA Registration Active 🇩🇪 Germany

Sterigenics Germany GmbH

Reg #: 3002807090 · FEI: 3006003617 · Expires 2026
Products
42
Proprietary Names
421
Establishment Types
1
Classifications
42

Registration Details

Registration Name
Sterigenics Germany GmbH
Registration Number
3002807090
FEI Number
3006003617
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Kasteler Straße 45
City
Wiesbaden Hesse
Country
DE

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
Set, Administration, Intravascular FPA
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
Gown, Surgical FYA
Hood, Surgical FXY
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Surgeon'S Gloves KGO
Medical Glove, Specialty LZC
Oxygenator, Cardiopulmonary Bypass DTZ
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
Catheter, Angioplasty, Peripheral, Transluminal LIT
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Electrosurgical, Cutting & Coagulation & Accessories GEI
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Console, Heart-Lung Machine, Cardiopulmonary Bypass DTQ
Neurological Stereotaxic Instrument HAW
Catheter, Percutaneous DQY
Stabilizer, Heart MWS
Endoscope, Neurological GWG
Labware, Assisted Reproduction MQK
Syringe, Piston FMF
Unit, Phacofragmentation HQC
Laser, Ophthalmic HQF
Instrument, Vitreous Aspiration And Cutting, Ac-Powered HQE
Implant, Orbital, Extra-Ocular HQX
Tray, Surgical, Instrument FSM
Drape, Surgical, Exempt PUI
Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
Heat-Exchanger, Cardiopulmonary Bypass DTR
Ventricular (Assist) Bypass DSQ
Probe, Thermodilution KRB
Instrument, Surgical, Non-Powered HAO
Applier, Surgical, Clip GDO
Clip, Scalp HBO
Orthopedic Stereotaxic Instrument OLO
Introducer, Syringe Needle KZH

Proprietary Names

ROTAFLOW Centrifugal Pump with BIOLINE Coating FLYTE HOOD W/PEELAWAY FLYTE PEELAWAY HOOD W/ WRAP Flyte Extended Hood w/Peelaway Flyte Extended Hood FLYTE HOOD FLYTE SURGICOOL HOOD W/PEELAWAY FLYTE SURGICOOL HOOD (28/CS) 0408-801-400 Flyte SurgiCool Hood 0408-801-500 Flyte SurgiCool Hood, Peelaway QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating "BMU Cell ½¿, 3/8¿, ¼¿,BMU Sensor 3/8¿, ¼¿, 3/16¿ Jackson-Pratt Wound Drainage Devices TRU-CLOSE Suction Drainage System Suction Reservoir Kit FLYTE TOGA, PULLOVER, L FLYTE TOGA, ZIPPER, L FLYTE TOGA, PULLOVER, 3X FLYTE TOGA, PULLOVER, 2X FLYTE TOGA, ZIPPER, 3X FLYTE TOGA, ZIPPER, XL FLYTE TOGA, PEELAWAY XL FLYTE TOGA, ZIPPER, 2X FLYTE TOGA, PEELAWAY, L FLYTE TOGA PEELAWAY, 3X FLYTE TOGA, PEELAWAY, 2X 0416-831-100 T7Plus Zippered Toga with Peel Away 0416-841-200 T7Plus Zippered Toga 0416-750-200 T7 Pullover Toga 0416-820-200 T7 Zippered Toga 0416-821-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-830-100 T7 Zippered Toga with Peel Away Face Shield 0416-730-200 T7 Pullover Toga 0416-801-200 T7Plus Hood 0416-801-000 T7Plus Hood with Standard Face Shield 0416-851-200 T7Plus Zippered Toga 0416-731-200 T7Plus Pullover Toga 0416-851-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-830-200 T7 Zippered Toga 0416-841-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-751-200 T7Plus Pullover Toga 0416-820-100 T7 Zippered Toga with Peel Away Face Shield 0416-850-200 T7 Zippered Toga 0416-831-200 T7Plus Zippered Toga 0416-850-100 T7 Zippered Toga with Peel Away Face Shield 0416-740-200 T7 Pullover Toga 0416-741-200 T7Plus Pullover Toga 0416-800-200 T7 Hood 0416-801-100 T7Plus Hood with Peel Away Face Shield 0416-821-200 T7Plus Zippered Toga 0416-721-200 T7Plus Pullover Toga 0416-840-200 T7 Zippered Toga 0416-840-100 T7 Zippered Toga with Peel Away Face Shield 0416-800-100 T7 Hood with Peel Away Face Shield Arterial HLS-Cannula, 13 Fr., non-coated, with BIOLINE and with SOFTLINE Coating Percutaneous Insertion Kits HLS-Set Advanced 7 and 5 HIT-Set Advanced 7 and 5 QUADROX-iR Adult / Small Adult, with and without integrated Arterial Filter, with BIOLINE or SOFTLINE Coating "QUADROX-iR Adult / Small Adult, with and without integrated Arterial Filter, with BIOLINE or SOFTLINE Coating; CranialMask Tracker FRAMELESS GUIDE T401261 Atlas Positioner T401209S Assitant with StableSoft 3L Atlas 360 Positioner Ultra Titan Stabilizer Long Shaft Attachment Titan Ultra Stabilizer Attachment T401245 StableSoft II Stabilizer - Long Shaft T401211S Assistant with StableSoft 2L T401231LS Titan Stabilizer Long Shaft JANKE-BARRON HEART SUPPORT T401231 Titan Stabilizer T401212S Assistant with StableSoft 2S T401210S Assistant with StableSoft 3S T401231U Titan 360 Stabilizer T401261U Atlas 360 Positioner Titan Stabilizer T401244 StableSoft II Stabilizer Atlas Positioner Atlas Positioner Attachment 9930/25 T401270 Suture Holder Insert 9945/25 Atlas 360 Positioner Titan Stabilizer Attachment, Long Shaft StableSoft II Stabilizer Titan 360 Stabilizer Attachment Suture Holder Insert Atlas 360 Positioner Attachment Titan Stabilizer - Long Shaft Attachment StableSoft II Stabilizer - Long Shaft Titan Flex Stabilizer Titan Flex 360 Stabilizer StableSoft Ultra Stabilizer OPVAC Synergy Ultra Transducer Cover Rapid-i Kit HLS Cannulae, non coated, with BIOLINE or SOFTLINE Coating "HLS Cannulae, non coated, with BIOLINE or SOFTLINE Coating QUADROX-i Adult with filter and with BIOLINE Coating QUADROX-iD Adult QUADROX-i Small Adult with BIOLINE Coating QUADROX-iD Adult with BIOLINE Coating QUADROX-i Adult QUADROX-i Adult with filter QUADROX-i Small Adult with filter QUADROX-i Small Adult QUADROX-i Adult with BIOLINE Coating QUADROX-i Small Adult with filter and with BIOLINE Coating EVA NEXUS Ophthalmic surgical system ROTAFLOW Centrifugal Pump Scleral Buckling Products Tray, Surgical Instrument PERI-LOC FORCEPS TRAY 3.5MM DSTL TIB CALC LK PL TRAY PERI-LOC CLAVICLE INST & IMPL TRAY CADDY {} SM PLATES {} BASIC PERI-LOC 2.7MM DR GD CADDY PERI-LOC VLP INSTRUMENT TRAY LID VLP FOOT COMPACT TRAY PERI-LOC 6.5MM SCREW/INSTRUMENT TRAY LID CADDY {} MINI INSTRUMENT PERI-LOC 6.5 CANC SCREW CADDY PROXIMAL FEMUR TARGETER OUTER TRAY LID Single Use Magnetic Transfer Zone 16" x 10" - Private Label NOVAPLUS 200-16B-V PROXIMAL FEMUR IMPLANT TRAY LID STER CASE-RINGS 80-130MM CADDY {} SM INSTS {} BASIC PERI-LOC VLP DIST TIB/FIB LOCK PL TRAY PERI-LOC VLP INSTRUMENT TRAY PERI-LOC CLAVICLE INST & IMPL TRAY LID VLP FOOT 3.5MM/5MM IMPLANT TRAY LID WIRE CADDY JET-X IMPLANT TRAY PERI-LOC SM FRAG SCREW CADDY PERI-LOC VLP AUXILIARY SCREW CADDY 4.5MM L-D FEMUR LK PL TRAY PERI-LOC SM FRG STR LCK PL CDY PERI 6.5MM CANC SCW CDY LD CABLE SADDLE AND LHI CADDY LID VLP 2.7MM/3.5MM BASE INSTRUMENT TRAY PERI-LOC PERI-ART FORCEPS TRAY LID 7MM SCREW CADDY LID LARGE FRAGMENT STRT PLT TRAY CADDY {} SM DRILLS PERI-LOC SM FRAG DRL GDE CADDY TRAY C {} PELVIC INSTS PERI-LOC VLP PROX TIB LOCK PL TRAY JETX 5MM XSHT HP INSRTN TRAY LID CADDY {} SM PLATES {} DELUXE LRG CANN SCR INSTR TRAY LID PROXIMAL FEMUR TARGETER INSTRUMENT TRAY STER CASE-RINGS {} 140-180MM VLP FOOT TEMPLATE TRAY SMALL CANN SCREW INSTRUMENT TRAY LID CADDY {} SM SCREWS {} BASIC HEX FIX COMPONENT TRAY PERI-LOC SM FRAG STR PL CADDY PERI-LOC 2.7MM SCREW CADDY LID RING CASE 155MM AND 180MM LID INSTRUMENT CASE LID VLP FOOT 2.7MM/4MM IMPLANT TRAY LID 4.5MM L-P TIB LK PLATES TRAY TRAY {} PELVIC INSTS VLP 2.7MM/3.5MM INSTRUMENT TRAY 6.5MM SCREW CADDY LID SMALL CANN SCREW CADDY LID TRAY B {} PELVIC INSTS 7MM CANN SCREW CADDY AESCULAP LID W/RETENTION PLATE SILVER AUXILLARY INSTRU MODULE STER CASE W-LID 3.5MM L-P TIB TGR TRAY 8MM CANN SCREW CADDY CADDY {} MINI PLATE CADDY {} MINI SCREWS LID {} CADDY {} MINI PLATES VLP FOOT IMPLANT TRAY VLP FOOT COMPACT TRAY LID PERILOC SM FRAG SCREW CDY LID PERI-LOC CLAVICLE PL CADDY LID Scalpel Holder LONG CANNULATED SCREW CADDY PERI-LOC VLP SCREW CADDY LID PERI-LOC SM FRAG BASIC INST TRAY LID TSF RINGS STER.TRAY Sharps Saf-T Zone w/o tray CADDY {} MINI DRILLS PERI-LOC PERI-ART FORCEPS TRAY 8MM SCREW CADDY LID WIRE CAP LID CADDY {} LG SCREWS PERI-LOC 4.5 S-T CRTX SCR CDY PERI-LOC 2.7MM INST & SCR TRAY TRAY LID FOR LRG CANN SCREW VLP 2.7mm/3.5mm INST TRAY LID STERILIZATION CASE-RINGS {} 200MM-240MM PERI-LOC SM FRG INST TRAY SPCR STER CASE-RODS {} POSTS Single Use Magnetic Transfer Zone 3" x 4 1/2" Sharps Saf-T Transfer Drape Non-Magnetic 32/case REF TR ACET LINR TRAY INS FRAME STABILIZER CASE VLP 2.7mm/3.5mm BASE INSTRUMENT TRAY LID PROXIMAL FEMUR TARGETER OUTER TRAY TRAY {} LG FORCEPS PERI-LOC VOL DST RAD TRY LID STER CASE-WIRES {} INST PERI-LOC 6.5 CANC SCR CDY LID 6.5MM CANN SCREW CADDY VLP FOOT IMPLANT TRAY LID SMALL CANN SCREW CADDY PL 3.5 STR LCK/NOLCK PL CDY LD PROXIMAL FEMUR IMPLANT TRAY Single Use Magnetic Transfer Zone 3" x 4.5" - Private Label Cardinal Health 100-10B STERIL TRAY F/SPAT FRAME STRUTS/WREN PERI-LOC 4.5 S-T COR SC CDY LD VLP 2.7MM/4MM IMPLANT TRAY 3.5MM L-P TIB LK PLT TRAY EUROPEAN PROX FEM INSTR TRAY JETX CENTRAL TR INSTR CASE PERI-LOC VDR SCRW CADDY LID CADDY {} SM INSTS {} DELUXE LID INSERT F/TSF ASSEMBLY WIRE CAP TRAY PERI 4.5MM CRTX SCRW CADY LD 3 HEADLESS/2 QFX SCREW CADDY DROP-IN PERI-LOC SM FRG SCREW CDY LID PERI-LOC SM FRG INS TRAY REV 1 VLP FOOT TEMPLATE TRAY LID RING CASE 130MM AND 205MM LID LARGE - UNI EXT FIX SYS INNER TRAY LID TRAY {} BLADE PLATES Single Use Magnetic Transfer Zone 16" x 20" -Private Label Cardinal Health 200-20B Single Use Magnetic Transfer Zone 16" x 10" Single Use Magnetic Transfer Zone 16" x 20" PERI-LOC LG FRG INS TRAY REV 1 REF TRIAL ACET SHELL TRAY 4.5MM L-D FMR TRGTR TRAY TRAY {} LG PLATES JETX HALF PIN INSERTION TRAY VLP 2.7mm/3.5mm ANCILLARY INST TRAY LID SM FRAG PLATE CADDY {} CP/PF PERI-LOC VLP SCREW CADDY PERI-LOC VLP PROX TIB LOCK PL TRAY LID HALF PIN MODULE STER CASE WITH LID CADDY {} SM PLATES {} DELUXE Single Use Magnetic Transfer Zone w/Tray 16" x 20" PERI 5.7MM CAN LCK SCW CDY LD PERI-LOC 4.5 S-T LK SCR CDY LD PERI-LOC VLP DRILL CADDY STER CASE-NUTS {} BOLTS PERI-LOC 4.5 S-T LCK SCR CADDY TRAY {} LG INSTRUMENTS PERI-LOC 5.7 CAN SCREW CDY LID TRAY A {} PELVIC RED INSTS AESCULAP BOTTOM CONT PERFORAT 135MM Single Use Magnetic Transfer Zone 16" x 10" - Private Label Leonhard Lang ST-12 P-L 2.7MM DRL GD CDY LD WIRE CADDY LID LONG CANN. SCREW CADDY LID JET-X 6MM HALF PIN INSERT TRAY VLP 3.5MM/5MM IMPLANT TRAY PERI-LOC ELBOW LCK PL TRY PERI-LOC LG FRAG SCREW TRAY PERI-LOC CLAVICLE PLATE CADDY PERI-LOC SM FRAG INST TRAY RING CASE 130MM AND 205MM Single Use Magnetic Transfer Zone w/ Tray 16" x 10" STER CASE-TELESCOPIC RODS PERI-LOC VOL DIST RAD TRY HARDWARE CASE LID LG - UNI EX FIX SYS OUT TRAY - TALL TRAY PERI-LOC 2.7MM INSTR&SCREW TRY LID {} CADDY {} SM SCREWS LRG CANN SCR INSTR TRAY FULL TRAY FOR LRG CANN SCRW SMALL CANN SCREW SYSTEM TRAY PERI-LOC VLP IMPLANT TRAY LID LID {} CADDY {} MINI SCREWS PERI-LOC VLP DIST TIB/FIB LK PL TRAY LID MAYO STAND CADDY LG FRAG PLATE TRAY {} CP/PF Single Use Non-Magnetic Zone 16" x 10" Single Use Magnetic Transfer Zone 16" x 10" - Private Label Cardinal Health 200-16B INSTRUMENT CASE OPTIONAL INSTRUMENT TRAY PERI-LOC VLP AUXILIARY SCREW CADDY LID 2.5/3 CANN SCREW CADDY DROP-IN SPATIAL FRAME HARDWARE CASE 4.5MM LP TIB TRGTR TRAY STERILIZATION TRAY DRS LG FRAG PLATE TRAY {} PF PERILOC 3.5MM STRT PL CDY LID CABLE SADDLE/HOLE FILLER CADDY PERI-LOC SM FRAG BASIC INST TRAY PERI-LOC 6.5MM SCREW/INSTRUMENT TRAY CHISEL BLADE RADIAL 13X120X1MM - 18S JET-X CENTRAL TRAUMA IMPL CASE PERI-LOC SM FRG STR LK PLT LID PERI-LOC LG FRAG SCREW CADDY TRAY {} PELVIC IMPLANTS PERI-LOCK 5.7 CANN LCK SCR CDY STER CASE-PLATES HEX FIX HALF PIN TRAY PERI-LOC 2.7MM LCK SCREW CADDY SMALL CANN SCREW INSTRUMENT INNER TRAY SMALL CANN SCREW SYSTEM LID 3.5MM D TIB TGTR TRAY RING CASE 155MM AND 180MM JETX MINI TRAY PERI-LOC VOL DST RAD SCRW CDDY AESCULAP BOTTOM CONT PERFORAT 90MM PIN, BLUNT, 2.4MM TSF PIN/WIRE STER TRAY CADDY F/TSF BOLTS {} WASHERS VLP 2.7MM/3.5MM ANCILLARY INST TRAY CADDY {} SM SCREWS {} DELUXE EUROPEAN PROX FEM INSTR TRAY LID SMALL CANN SCREW INSTRUMENT TRAY PERI-LOC VLP IMPLANT TRAY PERI-LOC SHLDR LCK PL TRY PERI-LOC SM FRAG DRILL CADDY LG - UNI EXT FIX SYS OUT TRAY - SH TRAY PERI-LOC 4.5MM LCK SCRW CDY LD NEEDLE COUNTER 80710CARD- Single Use Magnetic Transfer Zone 16" x 10" - Private Label Cardinal Health 200-16B 80730CARD- Single Use Magnetic Transfer Zone 3" x 4.5" - Private Label Cardinal Health 100-10B 80710- Single Use Magnetic Transfer Zone 16" x 10" 80720- Single Use Magnetic Transfer Zone 16" x 20" 80720CARD- Single Use Magnetic Transfer Zone 16" x 20" -Private Label Cardinal Health 200-20B DMEK Surgical Disposable Set 1508/25 SCCW01/20 KL701W/20 KL006/12 KL004/20 OR004/20 KL005W/20 KL001W/80 KL001/80 KP1826/25 KP2226/20 KP11829/50 1341/25 CFD024/20 KL002/40 19400/25 KLF200/20 KL703W/20 KL002W/40 KP11826/20 1528/25 KL004W/40 1648/25 0008 KL006/20 19405/50 1538/25 KL003/40 KL016W/10 1528W/10 1518/25 KL702W/20 PFD019/50 KL005/20 KL030W/03 1265/25 PHS 489150 KP1319F/50 KLF100/20 Robotic Arm Drape Halyard Drape ORS Drape Camera Drape Microtek Versisus Drape Drape, Surgical Versius Equipment Drapes Probe Covers Drape and Calibration target for use with ActivSight imaging system CoreVista® Monitor Drape Halyard Basics Drape Corin Camera drape Tablet Drape QUADROX-i Microporous Membrane Oxygenator w and w/o Arterial Filter with holding clamp EXCOR Pediatric PiCCO Catheter ROTAFLOW Centrifugal Pump with SOFTLINE Coating Integra NeuroBalloon Catheter KROLMAN INSTRUMENT Ad-Tech Obturators Wyler Transector NEUROBALLOON™ CATHETER Injectate Temperature Sensor Housing SPINEMASK TRACKER Duploject System Duploject Combi FLYTE TOGA, PULLOVER XL FLYTE SURGICOOL TOGA, ZIPPER 3X FLYTE SURGICOOL TOGA, PULLOVER, 3X FLYTE SURGICOOL TOGA, PULLOVER, XL FLYTE SURGICOOL TOGA, ZIPPER FLYTE SURGICOOL TOGA, Zipper PEELAWAY, L FLYTE SURGICOOL TOGA, PULLOVER, 2X FLYTE SURGICOOL TOGA, PEELAWAY, 2X FLYTE SURGICOOL TOGA, ZIPPER, 2X FLYTE SURGICOOL TOGA, ZIPPER, L FLYTE SURGICOOL TOGA, PEELAWAY, 3X FLYTE SURGICOOL TOGA, PEELAWAY FLYTE SURGICOOL TOGA, PULLOVER, L 0408-841-100 Flyte Surgicool Toga, 2XL, Zipper, Peelaway 0408-851-000 Flyte Surgicool Toga, 3XL, Zipper 0408-821-100 Flyte Surgicool Toga, L, Zipper, Peelaway 0408-831-000 Flyte Surgicool Toga, XL, Zipper 0408-851-100 Flyte Surgicool Toga, 3XL, Zipper, Peelaway 0408-821-000 Flyte Surgicool Toga, L, Zipper 0408-741-000 Flyte Surgicool Toga, 2XL, Pullover 0408-751-000 Flyte Surgicool Toga, 3XL, Pullover 0408-831-100 Flyte Surgicool Toga, XL, Zipper, Peelaway 0408-841-000 Flyte Surgicool Toga, 2XL, Zipper 0408-731-000 Flyte Surgicool Toga, XL, Pullover

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)