K-ONE MEDITECH SDN. BHD.

FDA Device Registration & Listing · Sekinchan Selangor, MY · Registration 3043535425

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043535425
FEI Number
3043535425
Entity Name
K-ONE MEDITECH SDN. BHD.
City/State/Country
Sekinchan Selangor, MY
Establishment Address
4B, Jalan JPT, Bagan Sekinchan, Sekinchan Selangor 45400, MY
Establishment Type(s)
Manufacture Medical Device,Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
K-One MediTech Sdn. Bhd. (Owner Number: 10095097)
Owner / Operator Contact Address
4B, Jalan JPT, Bagan Sekinchan, Sekinchan, MY-10 45400, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Steradian Shield Steradian Shield

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2026-01-23
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2026-01-23

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 →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043535425. Last updated year: 2026. Please use registration number 3043535425 when referencing this establishment in official correspondence.
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