Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014747754

FEI Number

3014747754

Entity Name

K-One MediTech Sdn. Bhd

City/State/Country

Ipoh Perak, MY

Establishment Address

68, Lengkok Rishah 2, Kawasan Perindustrian Silibin, Ipoh Perak 30100, MY

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

K-One MediTech Sdn. Bhd (Owner Number: 10058595)

Owner / Operator Contact Address

68, Lengkok Rishah 2, Kawasan Perindustrian Silibin, Ipoh, MY-08 30100, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

70352AZ- Weekly Pill Organizer Pill Box Rainbow Ezy Dose Medtime Planner 67706 Ezy Dose Pill Planner Weekly AM/PM with easy fill 67705 70353AZ-AM/PM Pill Planner Rainbow Ezy Dose Pill Planner Weekly with easy-fill 67704 Ezy Dose Pill Planner 67010 67010AMT3 WKLY AM/PM PILL PLNR 1/72 70352RA Rite Aid Weekly Pill Organizer PB RB 36/36 67705WG3 WG EASY FILL WKLY AM/PM 72/72 HK67010A WKLY AM/PM PILL PLNR 6/72 Steradian Shield Steradian Shield F414-436WM1 EQ First Aid Covers 6/24 Flent's Finger Cover: F414-405, F414-436, 69626 97203 Finger Covers-LG 6/72, F414-436WM EQ First Aid Covers 6/24

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2021-06-30
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2021-02-04
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2024-11-14
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-12-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-09-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-09-17
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-09-17
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-08-08
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2021-06-15

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

K-One MediTech 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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014747754. Last updated year: 2026. Please use registration number 3014747754 when referencing this establishment in official correspondence.