Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010175289

FEI Number

3010175289

Entity Name

Synergy Sterilisation Rawang (m) Sdn. Bhd.

City/State/Country

Rawang Selangor, MY

Establishment Address

Lot 42, Jalan Industri 2/1, Rawang Integrated Industrial Park, Rawang Selangor 48000, 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

BDPTE (RW) - BD Eclipse Injection Needle with BD Luer-Lok Syringe BDPTE (RW) - BD Eclipse Injection Needle with BD Luer-Lok Syringe WRP10943 (RW,KK) - Signature Latex Ortho

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-12-19
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-01-03
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2013-03-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-09-10
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-04-29
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-03-26
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-04-29
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-04-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-04-29
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2024-12-16
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-12-16
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-03-22
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-12-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010175289. Last updated year: 2026. Please use registration number 3010175289 when referencing this establishment in official correspondence.