Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038285067

FEI Number

3038285067

Entity Name

Synergy Sterilisation Kulim (M) Sdn. Bhd

City/State/Country

Seberang Perai Selatan Pulau Pinang, MY

Establishment Address

Plot 329F, Jalan Cassia Selatan 6/4,Kawasan Perindustrian Batu Kawan, Kawasan Perindustrian Batu Kawan, Seberang Perai Selatan Pulau Pinang 14110, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dexcom10877 (KK,BK) - Dexcom G7 15-Day Continuous Glucose Monitoring System Dexcom10877 (KK, BK) - Stelo Glucose Biosensor System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-12-23
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-12-23
SAF	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter	Clinical Chemistry	Class 2	862.1355	2025-04-22

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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038285067. Last updated year: 2026. Please use registration number 3038285067 when referencing this establishment in official correspondence.