Data / Medical devices / Malaysia / K-One MediTech Sdn. Bhd

K-One MediTech Sdn. Bhd: FDA-registered device maker in Ipoh Perak, Malaysia, 1 510(k) clearance

Name: K-One MediTech Sdn. Bhd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

K-One MediTech Sdn. Bhd is registered with the FDA (registration 3014747754) in Ipoh Perak, Malaysia. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 2, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014747754
Address: 68, Lengkok Rishah 2, Kawasan Perindustrian Silibin, Ipoh Perak, Malaysia, 30100
Owner or operator: K-One MediTech Sdn. Bhd (10058595)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: October 12, 2018
Registered through: 2026
Brand names listed: 67010AMT3 WKLY AM/PM PILL PLNR 1/72, 67705WG3 WG EASY FILL WKLY AM/PM 72/72, 70275CV2 CVS WEEKLY PILL PLANNER 2CT 36/36, 70352AZ- Weekly Pill Organizer Pill Box Rainbow, 70352RA Rite Aid Weekly Pill Organizer PB RB 36/36, 70353AZ-AM/PM Pill Planner Rainbow, 70551A HEAR HUSH HOOPS 3/18, 70551BKAMZ1 HEAR HUSH HOOPS BLACK 1/72 and more

Devices it lists

Device	Product code	Class	Role	Source
Anesthesia Breathing Circuit Kit (Adult & Pediatric)	OFP	1	Repackager or relabeler	accessdata.fda.gov
Bag, Ice	KYR	1	Contract manufacturer	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Repackager or relabeler	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Repackager or relabeler	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Repackager or relabeler	accessdata.fda.gov
Pill Crusher/Cutter	OHY	1	Contract manufacturer	accessdata.fda.gov
Protector, Hearing (Insert)	EWD	U	Contract manufacturer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Syringe, Antistick	MEG	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 2, 2017	K170651	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	MEG	Substantially Equivalent	Yangzhou Medline Industry, Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 2, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.