VORK TECHNOLOGIES (MALAYSIA) SDN. BHD.

FDA Device Registration & Listing · Senai Johor, MY · Registration 3040108652

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
3040108652
FEI Number
3040108652
Entity Name
VORK TECHNOLOGIES (MALAYSIA) SDN. BHD.
City/State/Country
Senai Johor, MY
Establishment Address
No.58 & 59, Jalan I-Park SAC 7, Taman Perindustrian I-Park SAC, Senai Johor 81400, MY
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
VORK TECHNOLOGIES (MALAYSIA) SDN. BHD. (Owner Number: 10095495)
Owner / Operator Contact Address
No.58 & 59, Jalan I-Park SAC 7, Taman Perindustrian I-Park SAC, Senai, MY-01 81400, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

IP ActivFlo Biopsy I, Taped Vaporizer (Humidifier)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IDZ Cassettes, Tissue Pathology Class 1 864.3010 2026-03-19
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2026-03-19

Official Correspondent

ZHONGSHAN YANG

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

VORK TECHNOLOGIES (MALAYSIA) 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 3040108652. Last updated year: 2026. Please use registration number 3040108652 when referencing this establishment in official correspondence.
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