FDA Registration
Active
🇲🇽 Mexico
Sterigenics S. de R.L. de C.V.
Reg #: 9616517
·
FEI: 3003117688
·
Expires 2026
Products
6
Proprietary Names
243
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Sterigenics S. de R.L. de C.V.
- Registration Number
- 9616517
- FEI Number
- 3003117688
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Parque Industrial Tepeji, Calle North 7 s/n
- City
- Tepeji del Rio de Ocampos Hidalgo
- 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 |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-07-05 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2013-01-28 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2010-06-11 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2025-05-20 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2017-07-05 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2017-07-05 |
Proprietary Names
Xi Seal (5 to 8mm) - 470361
5-8 mm Cannula Seal - 470361
560 ISO S P P C C E W144 140
560 ISO S P P C C E W144 90 - 140
LEXICON ABS S P P ISO W180 15
565 AUXILIARY S P P W144 X C
560 ISO S P P C C E W180 50
560 ISO S P P C C E W180 35
ABSORBENT S P P MAILLEFER W180 60
560 ISO S P P C C E W180 40
560 ISO S P P C C E W180 15 - 40
560 ISO S P P C C E W180 30
LEXICON ABS S P P ISO W180 45-80
ABSORBENT S P P MAILLEFER W180 XXF-XC
ABSORBENT S P P MAILLEFER W180 70
LEXICON ABS S P P ISO W180 15-40
560 ISO S P P C C E W180 20
ABSORBENT S P P MAILLEFER W180 F
ABSORBENT S P P MAILLEFER W180 C
565 AUXILIARY S P P W180 F
560 ISO S P P C C E W180 15
560 ISO S P P C C E W180 45
560 ISO S P P C C E W144 90
560 ISO S P P C C E W144 100
LEXICON ABS S P P ISO W180 20
LEXICON ABS S P P ISO W180 25
ABSORBENT S P P MAILLEFER W180 XF
LEXICON ABS S P P W180 F
ABSORBENT S P P MAILLEFER W180 55
LEXICON ABS S P P ISO W180 55
565 AUXILIARY S P P W180 XXF-C
560 ISO S P P C C E W144 130
560 ISO S P P C C E W180 25
ABSORBENT S P P MAILLEFER W180 20
ABSORBENT S P P MAILLEFER W180 30
LEXICON ABS S P P ISO W180 50
560 ISO S P P C C E W180 80
ABSORBENT S P P MAILLEFER W180 M
LEXICON ABS S P P W180 XF
LEXICON ABS S P P W180 XXF-XC
ABSORBENT S P P MAILLEFER W180 15-40
ABSORBENT S P P MAILLEFER W180 15
560 ISO S P P C C E W180 70
ABSORBENT S P P MAILLEFER W180 45
560 ISO S P P C C E W180 60
565 AUXILIARY S P P W180 M
ABSORBENT S P P MAILLEFER W180 35
560 ISO S P P C C E W180 55
LEXICON ABS S P P ISO W180 40
ABSORBENT S P P MAILLEFER W180 25
LEXICON ABS S P P ISO W180 80
ABSORBENT S P P MAILLEFER W180 XC
LEXICON ABS S P P W180 M
LEXICON ABS S P P ISO W180 30
ABSORBENT S P P MAILLEFER W180 50
ABSORBENT S P P MAILLEFER W180 40
ABSORBENT S P P MAILLEFER W180 80
565 AUXILIARY S P P W180 XX F
560 ISO S P P C C E W144 110
LEXICON ABS S P P W180 X-C
LEXICON ABS S P P ISO W180 70
LEXICON ABS S P P W180 C
LEXICON ABS S P P ISO W180 45
565 AUXILIARY S P P W180 C
LEXICON ABS S P P ISO W180 60
560 ISO S P P C C E W144 120
560 ISO S P P C C E W180 45 - 80
ABSORBENT S P P MAILLEFER W180 45-80
LEXICON ABS S P P ISO W180 35
565 AUXILIARY S P P W180 X F
Precise Dental
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
Ocu-Dot Tonometer Probes-100 Count
Ocu-Film® + Tip Covers
Xi Conductive Reducer - 470381
Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09)
Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07)
Si Stapler Sheath - 410370
Xi Stapler 45 Reload (Blue) - 48645B
Xi Seal (12mm & Stapler) - 470380
12 mm & Stapler Cannula Seal - 470380
Xi Stapler 45 Reload (White) - 48645W
Xi Stapler 45 Reload (Green) - 48445G
Xi Optical Obturator (12mm & Stapler, Standard), (470403-01 &-02)
Xi Optical Obturator (12mm & Stapler, Long), (470404-01 & -02)
Xi Optical Obturator (8mm, Standard), (470359-01 &-02)
Xi Optical Obturator (8mm, Long), (470360-01 &-02)
Xi Optical Obturator (12mm & Stapler, Standard) - 470403
8 mm Bladeless Obturator - 470359
Xi Optical Obturator (12mm & Stapler, Long) -470404
Xi Optical Obturator (8mm, Standard) - 470359
Xi Optical Obturator (8mm, Long) - 470360
8 mm Bladeless Obturator, Long - 470360
Da Vinci Xi 12 8 mm Reducer - 470381
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)