FDA Registration
Active
🇲🇽 Mexico
Sterigenics S. de R.L. de C.V.
Reg #: 3008328679
·
FEI: 3008328679
·
Expires 2026
Products
10
Proprietary Names
290
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Sterigenics S. de R.L. de C.V.
- Registration Number
- 3008328679
- FEI Number
- 3008328679
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- James Watt No. 22, Parque Industrial Cuamatla
- City
- Cuautitlan Izcalli Mexico
- Country
- MX
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 |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-06-05 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2025-07-29 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2025-07-29 |
| Hood, Surgical | FXY | Class 2 | General, Plastic Surgery | No | 2017-08-10 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2010-06-11 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2012-10-29 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2017-08-10 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2026-05-05 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2026-05-05 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2026-05-05 |
Proprietary Names
0707-002-000 Autoplex M4 Cement Mixer for Manifold with Vertaplex HV Bone Cement
0707-000-000 Autoplex M4 Cement Mixer with Vertaplex HV Bone Cement
FLYTE SURGICOOL HOOD W/PEELAWAY
FLYTE SURGICOOL HOOD (28/CS)
0408-801-400 Flyte SurgiCool Hood
0408-801-500 Flyte SurgiCool Hood, Peelaway
07 0010 Samco Bio-Tite, 90mL, Midstream Kit with Funnel
02 0016 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap
02 0002 Cardinal Health Specimen Container, 90mL/48mm, ORG Cap
container, specimen, sterile Vacuette No -Additive Tubes
Clikseal
Portex Speciman Trap
Midstream Kit (Container Specimen)
Pathology Container, Snap Cap, PN 0480-1101
Pathology Container, Snap Cap, PN 0450-1101
Pathology Container, Snap Cap, PN 0450-1111
1008/100
1002/36
Pathology Container, Snap Cap, PN 0501-1101
19227/12
B0810/50
Pathology Container, Snap Cap, PN 0480-1111
B0612/100
17531/50
B1708/50
TP002/50
1060/50
1050/50
PSS001/25
TP0014/50
B2923/50
B1212/25
17511/20
1005W/25
B1706/50
MHBFK01/10
JBQ773
1004/36
17531/20
PDC001/20
KB006L/20
B1111Z/25
B1912/100
B1710/100
1055/50
B1115Z/50
B0633/50
1013/100
1007/50
1070/50
SSB001/10
17555/50
B0606/25
BCP300/100
B0652/10
TP0015/50
17511C/20
TP0016/50
TP003/200
1001R/36
1055/75
SJMC001/10
B1215/100
Catch Kit: 25000
Speciman Cup: 8889207026
Corning Cryogenic vials and accessories
Speciman Collection: 2600SA
Catch Kit: 22000
Speciman Collection: 2090SA
430490
430661
430489
Speciman Container: 15000
Speciman Collection: 2205SA
431422
Speciman Collection: 2040SA
Catch Kit: 22015
430663
430658
Speciman Collection: 2300SA
Catch Kit: 25015
Speciman Collection: 2210SA
430659
430179
352001
Speciman Cup: 8889207067
Speciman Collection: 4090SA
Speciman Container: 45117
Speciman Collection: 17099
Speciman Collection: 2200SA
352045
352006
Speciman Container: 14999
Speciman Container: 14000
431421
354015
Speciman Collection: 2650SA
352003
430488
Vitronova
431386
430487
430491
431418
430656
352037
431458
430492
354013
431420
431417
431419
430662
90ORG53-1001
90ORG53-1000
90WHT53-1000 SAMCO 90mL/53mm CLK SPC LBL WT CAP ST
5000-0020 Nalgene Cryogenic Tube, 2 mL externally-threaded
5005-0015 Nalgene Specimen Cryogenic Vial, 15 mL externally-threaded
02 1090 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, ORG Cap
90WHT53-1001 Samco Clicktainer Vial, WHT Cap, 90mL, 53mm, w/lab, temp strip, ST
90ORG53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, ORG Cap
07 0002 Samco Bio-Tite, ST, 120mL, 53mm Midstream Kit No Funnel
03 0006 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, ORG Cap
07 0001 Samco Bio-Tite, ST, 90mL, 48mm Midstream Kit with Funnel
22-2090 Samco Bio-Tite Wide Mouth, ST, 90mL, 53mm, w/lab, YEL Cap
02 1016 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, WHT Cap
120WHT53-3000 Samco Clicktainer Vials, ST, 120mL, 53mm, Midstream Kit, no fnl
01 0001 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, ORG Cap
CHB13905 Cardinal HealthTM Specimen Container, O/R Pouch 120mL/53mm
120ORG53-1000 Samco Clicktainer Vials, ST, 120mL, 53mm, w/lab, ORG Cap
90ORG53-1001 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, ORG Cap, dsp box
5005-0015 Nalgene Specimen Cryogenic Vial, 15 mL externally-threaded
02 0002 Cardinal HealthTM Specimen Container, 90mL/48mm, ORG Cap
01 0002 120ml/53mm SPCw/LBL, WH CAP,ST
02 0039 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, WHT Cap
120ORG53-4000 Samco Clicktainer Vials, ST, 120mL, 53mm, O/R Pouch, ORG Cap
02 1038 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap
02 0214 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box
CHB13904 Cardinal HealthTM Specimen Container 120mL/53mm
90WHT53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, WHT Cap
120ORG53-4000
22 610 131 Fisherbrand 60mL, 48mm, ST, w/lab and temp strip, WHT Cap
120WHT53-4000
03 0008 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, Green Cap
07 0020 Samco Bio-Tite, 120ml, Midstream Kit, no funnel
CHB13903 Cardinal HealthTM Specimen Container 90mL/53mm
5000-0050 Nalgene Cryogenic Tube, 5 mL externally-threaded
01 0038 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap
CHB13902 Cardinal HealthTM Specimen Container 90mL/48mm
120WHT53-1000 Samco Clicktainer Vials, ST, 120mL, 53mm, w/lab, WHT Cap
07 0000 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, no lab, ORG Cap
90WHT53-1002 Samco Clicktainer Vial, ST, 90mL, 53mm, w/temp strip, WHT Cap
90GRN53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, GRN Cap
03 0007 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, WHT Cap
02 0038 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, Natural Cap
120WHT53-4000 Samco Clicktainer Vials, ST, 120mL, 53mm, O/R Pouch, WHT Cap
General Surgical Instrument
ER2 Saturate Mixing System
VORTEX & MIXOR NOZZLE UMBRELLA
VORTEX ADAPTER
VORTEX VACUUM MIXING SYSTEM
VACUUM TUBE W/SUC BYPASS
VORTEX & MIXOR NOZZLE ANGLED
VORTEX VACUUM BOWL
VORTEX&MIXOR NZLE STAND BRKAWY
MIXOR FEMORAL PRESSURIZER-LG
KYPHON® Mixer
VORTEX RE-USE KIT
VORTEX & MIXOR NOZZLE REVISION
VORTEX&MIXOR NZLE LONG TAPERED
0206-548-000
0206-547-000
0206-556-000
0206-566-000
0206-545-000
0206-546-000
0206-509-000;0206-564-000
HiVac Bowl Bone Cement Mixing System B713
0506-482-000
0605-685-015
0606-573-000
0606-583-000
0306-564-000
0606-705-000
0506-689-015
0605-683-015
0606-595-000
0506-486-000
0606-509-000
MiniMix LV Bone Cement Mixing System SMLV
0605-687-015
0605-887-000
0506-685-015
0606-516-000
Medium Port MiniMix Bone Cement Mixing System SMMM1
RALLY Vacuum Mixing Bowl 7127-1801
0506-483-000
Mixing Bowl, Spatula B710
0606-593-000
0606-515-000
0606-517-000
0606-514-000
0707-001-000 AutoPlex M4 Cement Mixer
0506-489-000
0606-553-000S1
Kyphon Mixer
0606-705-000S1
0306-553-000S2
0506-485-000
0606-512-000
0606-593-000S1
0606-565-000
0506-686-015
0606-520-000
0506-683-015
0506-682-015
0606-518-000
0606-553-000
0606-563-000
0306-563-000
0306-573-000
0506-687-015
FLYTE HOOD W/PEELAWAY
FLYTE PEELAWAY HOOD W/ WRAP
Flyte Extended Hood w/Peelaway
Flyte Extended Hood
FLYTE HOOD
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
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
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)