FDA Registration
Active
🇹🇭 Thailand
STERIS TOMOE (Thailand) Ltd.
Reg #: 3017616393
·
FEI: 3017616393
·
Expires 2026
Products
13
Proprietary Names
7
Establishment Types
1
Classifications
13
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Registration Details
- Registration Name
- STERIS TOMOE (Thailand) Ltd.
- Registration Number
- 3017616393
- FEI Number
- 3017616393
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 700/644 Moo 3, Tambon Bankao, Amphur Panthong
- City
- Chonburi Chon Buri
- Country
- TH
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS CORPORATION
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2013-04-05 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2013-04-05 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2020-10-06 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-12-09 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-12-09 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-01-24 |
| Trabeculotome | HMZ | Class 1 | Ophthalmic | No | 2026-04-29 |
| Pump, Infusion, Ophthalmic | MRH | Class 2 | General Hospital | No | 2026-04-29 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2026-04-29 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2026-04-29 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2023-11-08 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2013-12-30 |
Proprietary Names
Rover35148 (VL) - Rovers Anex Brush
SteripackPoland (RB,DK,VL2,) - Sterile Flocked Swab; Sterile Foam Swab; SteriPack Sterile Polyester Spun Swab and Swab
SteriPack9541 (RB,DK,VL2) - Sterile Polyester Spun Swab
Rover35148 (VL) - Rovers Evalyn Brush
PTMedtech16656 (CB2) - OMNI Edge Surgical System; OMNI Surgical System
PTMedtech16656 (CB2) - Aveta Fluid Management Accessory
PTMedtech16656 (CB2) - SION Surgical Instrument
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)