ELECTRON BEAM SDN BHD

FDA Device Registration & Listing · Port Klang Selangor, MY · Registration 3008252486

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
3008252486
FEI Number
3008252486
Entity Name
ELECTRON BEAM SDN BHD
City/State/Country
Port Klang Selangor, MY
Establishment Address
Lot 7 Jalan Sungai Pinang 4/3, Pulau Indah Industrial Park Phase 2, Port Klang Selangor 42920, MY
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

Ambu10292 (PK) - Neuroline Concentric Needle Electrode (740) 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HDC Tenaculum, Uterine Obstetrics/Gynecology Class 2 884.4530 2023-08-03
BWH Forceps, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2023-11-08
IWP Radiographic Protective Glove Radiology Class 1 892.6500 2020-01-15
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2022-04-15
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2013-01-24
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2013-12-30

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
3017616393 STERIS TOMOE (Thailand) Ltd. Chonburi Chon Buri, TH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K152984 Bio Protech, Inc. Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes 2016-06-03

Similar Registrations

Registration Number Establishment Name Location
9710524 ULTIMATE MEDICAL PRODUCTS LTD. SHARJAH Ash Shariqah, AE
8010665 SUBAN Instruments Germany GmbH TUTTLINGEN Baden-Wurttemberg, DE
9614068 TRACK OF SURGICAL SIALKOT Punjab, PK
3009988302 STERIPACK ASIA SDN BHD Klang Selangor, MY
9611112 HEBUMEDICAL GMBH TUTTLINGEN Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008252486. Last updated year: 2026. Please use registration number 3008252486 when referencing this establishment in official correspondence.
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