FDA Registration
Active
🇹🇭 Thailand
Sterigenics Thailand Ltd.
Reg #: 3004681601
·
FEI: 3004681601
·
Expires 2026
Products
8
Proprietary Names
291
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- Sterigenics Thailand Ltd.
- Registration Number
- 3004681601
- FEI Number
- 3004681601
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 109/16 Eastern Seaboard Industrial Estate Moo 4, Tambol Pluak Daeng, Amphur Pluak Daeng
- City
- Rayong Province
- Country
- TH
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 |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2012-10-24 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2021-04-02 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2019-08-15 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-02-26 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-05-02 |
| Instrument, Biopsy, Suction | FCK | Class 2 | Gastroenterology, Urology | No | 2019-12-20 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2012-11-15 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2009-05-13 |
Proprietary Names
12GA EnCor Probe Upright
EnCor /VisilocMRI Introducer
12 GA Probe Introducer
EnCor Introducer 12G
10 GA Product Introducer
EnCor/Visiloc 10G MRI Introducer Set
EnCor Introducer 10G
12GA EnCor
10GA SS Probe Introducer
Visitec
Applicator Absorbent tipped Sterile
Nylon fiber swab sterile
NuFoamSwabs
BD BBL Flocked Swab
CLASSIQSwabs
FLOQSwabs
Rayon fiber swab sterile
Polyester fiber swab sterile
Foam swab sterile
Cotton fiber swab sterile
Rovers Anex Brush
Rovers Anex Brush RT
9312M/50
9305/50
9320/100
9399/50
9740/50
9706/25
9625D/100
9713/50
S FPDLRS 0100 R02401 FBB {FIRST AID 100/24 STER WRAP}
9312/100
19602/20
9714/50
9702/50
96100/10
9605M/100
9606/100
9612P/100
9612D/100
9606M/100
9612/100
9325/100
9311P/100
9325D/100
9610G/100
9306/100
9318/100
9733/50
9310/100
9606/50
9712/100
9736/50
9605/100
9706/100
9650/50
9625/100
S SDDLR 0125 R03606 FBB {FIRST AID SWABS 36/125 WD 6PK}
9305/100
9710/25
9603M/100
9716/50
9350/100
9705/50
9716/25
9606L/100
9320P/100
9706/50
9620/100
9605/50
9350P/100
96110/50
9610/100
9703/50
9615/25
9310P/100
9611/100
96100/50
9718/100
Techniswab
Rovers Evalyn Brush
Microbrush Test Swabs
rbi2 suction rectal biopsy system
Fiber, Medical, Absorbant
Medical Cotton Ball
3144/24
8423/50
3264/24
3164/24
B PLDL 1000 R00201 AC {APCS COTTON BALL LAR 2/1000}
4250/50
4232/32
8462/50
B FMDLS 0130 R03606 TC {TOPCARE STER CB MED 36/130}
B FMDLS 0500 R01201 US {USC BL M COT STER 12/500 USC S}
8461/50
8418/50
B PMDL 2000 R00201 US {USC COTTON BALL MED 2/2000}
3124/24
8415/50
8102/50
8201/50
8418/20
MED3034/24
8103/50
8460W/10
8418W/20
8023/50
B FMDLS 0130 R02401 HM {HEALTH MART STER CB MED 24/130}
B FMDLS 0130 R03606 TA {TGT STER CB 36/130 245-07-0577}
8009/50
8468/50
WTL2025/25
8401/05
3034K/24
8401WNPP/05
MED3224/24
8415/05
4255/50
B PJDL 1000 R00201 US {USC COTTON BALL LG 1000/2}
MED3144/24
3064/24
8002/50
3134/24
3264W/24
8456/10
8401WH/05
MED3064/24
8021/50
MED3234/24
3564/20
3534/20
B FMDLS 0130 R02401 GD {GOODNEIGHBOR STE CB MED 24/130}
8401WN/05
8210/100
MED3024/24
B PXDL 0500 R00401 US {USC COT BALL EXTRA LARGE 4/500}
10110/100
8465W/10
10105/100
8422/20
3064W/24
MED3264/24
3024K/24
UMW002/50
3544/20
8101/100
B FMDLS 0130 R03601 WG {WALGREEN STERILE 36/130 340996}
17460/20
8441/50
8250/50
8105/100
MED3044/24
8408/20
3064/24S
8430/06
8420/20
8215/100
8428/20
8412/20
3234/24
8030W/05
8010/50
8205/100
UMW001/50
3244/24
8011/50
8468/20
10120/50
MED3244/24
8402/20
B FMDLS 0130 R03606 AHL {CAREONE STERILE CB MED 36/130}
3024/24
8014/50
8105U/50
3044W/24
8102/100
3034W/24
3064K/24
3524/20
8414/50
MED3124/24
8405/50
8416/20
8201/100
8406W/10
8205W/100
MED303424/24
8440W/10
8469/10
16063/20
MED3164/24
8305/100
8204/50
8453W/50
3224/24
8401W/05
8020/50
8203/100
3044/24
10205/100
B FMDLS 0130 R02406 FBB {FIRST AID 24/130 STER BALL MED}
8202/100
8436W/25
B FMDLS 0130 R02401 SM {SUNMARK STER CB MED 24/130}
4270/50
8013/50
8436W/20
B FMDLS 0130 R02406 LE {LEADER 24/130 STERILE BALL MED}
8470/10
8106/50
8022/50
8110/100
4260/25
17440/20
B PMDL 2000 R00201 FH {FISHER COT BALL MED 2/2000}
B FMDLS 0130 R02401 PB {PUBLIX STER CB MED 24/130}
8404/20
3034/24
8429W/20
8413/50
3044K/24
4"x5yards Primacare Elastic Bandage
3"x5yards Primacare Elastic Bandage
Flannel Bandage 4"
6"x5yards Primacare Elastic Bandage
Flannel Bandage 6"
Mini Compression Bandage
Big Cinch Bandage
4825/25
4016/24
4965C/24
4066/24
MED4835/25
4865/25
4065/24
4225/25
4845UW/25
4745/25
4570/24
4945C/24
4015/30
4047/24
4145/24
4025/24
4265/25
4725/25
4545/25
4045/24
4535/25
4036/24
MED4825/25
4067/24
4525/25
4245/25
4565/25
4026/24
4235/25
4835UW/25
4046/24
4048/24
4760/25
4165/24
MED4845/25
4735/25
MED4865/25
4590/24
4845/25
4825UW/25
4865UW/25
4765/25
4925C/24
4835/25
4580/24
4765/10
4125W/24
4146/10
4885/24
4935C/24
4540/24
4035/24
4125W/25
Thin H Bandage
H Bandage
Emergency Compression Dressing
BANDAGE GAUZE ROLL
Esmark Bandages
Sterile Premium Orthopaedic Wraps
7GA EnCor MRI
7GA EnCor
7GA EnCor Upright
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)