FDA Registration
Active
🇨🇳 China
Sterigenics Shanghai E Beam Ltd.
Reg #: 3008132411
·
FEI: 3008132411
·
Expires 2026
Products
13
Proprietary Names
308
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- Sterigenics Shanghai E Beam Ltd.
- Registration Number
- 3008132411
- FEI Number
- 3008132411
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- A603 Lane 108, No. 588, Chuantu Road, ChuanSha, Pudong
- City
- Shanghai
- Country
- CN
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 |
|---|---|---|---|---|---|
| Submucosal Injection Agent | PLL | Class 2 | Gastroenterology, Urology | No | 2023-08-04 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2023-08-24 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2023-08-24 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-07-13 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-07-13 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2013-02-04 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2010-06-11 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-07-30 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2025-07-30 |
| Immunoglobulin G (Igg) Infusion System | PKP | Class 2 | General Hospital | No | 2025-07-30 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2017-03-21 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-11-12 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-19 |
Proprietary Names
ArcScan Insight 100
ED3 EyeSeal
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
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
KA2210/25
KA2110/50
TRU-FIX Catheter Fixation Kit
KA1224/50
KA2210/50
KA1154/25
KA2254/25
KA1124/100
KA2310W/25
KA2154/50
MTS003/100
KA2130/50
KA1124/25
Zip DS Dressing Shield
Bandages
KA1118/50
KA2211/25
KA1254/25
OPSITE, IV3000 Frame Delivery
COVRSITE Plus
OPSITE, IV3000 1-Hand
Breg
OPSITE, IV3000 1-Hand Ported
OPSITE Post Op, IV 3000
OPSITE Flexigrid, IV3000 Standard
Skin Fix
OPSITE Flexigrid, IV3000 Ported
Tape & Bandage, Adhesive - 004792,004793,004794,004795, 004796,002970,003008,003276, 004342,003175,004322,005121, 005001
Incise Film
BAND-AID® Brand TOUGH STRIPS® Bandages
TrialOn
BAND-AID® Brand Flexible Fabric Bandages
Tube Holder 100/case
Tube Holder White
Dressings (Breg)
SureSeal Pressure Bandage
Primapore
CovRsite
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
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)