Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009988302

FEI Number

3009988302

Entity Name

STERIPACK ASIA SDN BHD

City/State/Country

Klang Selangor, MY

Establishment Address

Lot 119992, Jalan Canang Emas 8,, Telok Gong, Klang Selangor 42000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SteriPack Asia Sdn Bhd (Owner Number: 10043162)

Owner / Operator Contact Address

Lot 119992, Jalan Canang Emas 8,, Telok Gong, Klang, MY-10 42000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Carevix Double Pump Day Cassette Double Pump Single Double Pump RF Patient Cassette Double Pump Patient Cassette CarbonMini CarbonAid BIOBRANE Dressing BIOBRANE Glove

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDC	Tenaculum, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2023-03-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-01-29
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2013-01-29
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-01-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-01-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-06-22
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2020-09-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-03-09

Official Correspondent

Wai Woon Khoo

US Agent Details

Marinela Cebic Business: SteriPack USA (Limited) LLC Email: m.cebic@steripackgroup.com Phone: (863) 6482333

Related Public Records

Same Entity

SteriPack Asia Sdn Bhd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.

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
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY
9614068	TRACK OF SURGICAL	SIALKOT Punjab, PK
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 3009988302. Last updated year: 2026. Please use registration number 3009988302 when referencing this establishment in official correspondence.