STERIS TOMOE (Thailand) Ltd.

FDA Device Registration & Listing · Chonburi Chon Buri, TH · Registration 3017616393

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017616393
FEI Number
3017616393
Entity Name
STERIS TOMOE (Thailand) Ltd.
City/State/Country
Chonburi Chon Buri, TH
Establishment Address
700/644 Moo 3, Tambon Bankao, Amphur Panthong, Chonburi Chon Buri 20160, TH
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 10042227)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2013-04-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-04-05
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-18
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2020-10-06
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-12-09
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-12-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-12-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2013-01-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2013-04-05
HMZ Trabeculotome Ophthalmic Class 1 886.4350 2026-04-29
MRH Pump, Infusion, Ophthalmic General Hospital Class 2 880.5725 2026-04-29
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-01-10
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2026-04-29
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2026-04-29
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS CORPORATION Email: becky_aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K002933 Maxxim Medical STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES 2000-10-19
K913402 Smith & Nephew Perry PERRY(R) DERMAGUARD(R) PLUS GLOVES 1991-10-02
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21

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3004122598 PRODUCTOS MEDLINE S.A. DE C.V. NUEVO LAREDO Tamaulipas, MX
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017616393. Last updated year: 2026. Please use registration number 3017616393 when referencing this establishment in official correspondence.
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