Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011621895

FEI Number

3011621895

Entity Name

LKL ADVANCE METALTECH SDN BHD

City/State/Country

Seri Kembangan Selangor, MY

Establishment Address

Wisma LKL, No 3, Jalan BS7/18, Kawasan Perindustrian Bukit Serdang, Seri Kembangan Selangor 43300, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LKL Advance Metaltech Sdn Bhd (Owner Number: 10053248)

Owner / Operator Contact Address

Wisma LKL, No 3, Jalan BS7/18, Kawasan Perindustrian Bukit Serdang, Seri Kembangan, MY-10 43300, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blood Donor Chair Thomas Splint Siderail with Control Button Hospital Chemsafe Mattress Medi-Flex Mattress Chemsafe Child Cot Mattress Pressure Reducing Mattress Examination Light Hospital Ambulance Stretcher Hospital Fixed Height Bed Adult Cot Canvas Bed Full Length Siderail Hospital Collapsible Siderail Child Cot Midi-Length Siderail Hospital Mechanical Hi-Lo Bed Telescopic Siderail Manual Crank Bed Hospital Electrical Bed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FML	Chair, Blood Donor	General Hospital	Class 1	880.6140	2016-11-14
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2016-11-14
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2016-11-14
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2016-11-14
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2016-11-14
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2016-11-14
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2026-04-07

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: EMERGO GLOBAL REPRESENTATION LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

LKL Advance Metaltech 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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

Similar Registrations

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3001644167	Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, DE
3027847726	Paras Surgico Factory	Delhi, IN
1932952	DACOR MANUFACTURING, LLC.	Fenton, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011621895. Last updated year: 2026. Please use registration number 3011621895 when referencing this establishment in official correspondence.