GLOBAL TECH PLASTIC INDUSTRY SDN BHD

FDA Device Registration & Listing · ULU TIRAM Johor, MY · Registration 3027381586

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
3027381586
FEI Number
3027381586
Entity Name
GLOBAL TECH PLASTIC INDUSTRY SDN BHD
City/State/Country
ULU TIRAM Johor, MY
Establishment Address
NO.4,5,6, JALAN TIRAM 5, TAMAN PERINDUSTRIAN TIRAM, ULU TIRAM Johor 81800, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
GLOBAL TECH PLASTIC INDUSTRY SDN BHD (Owner Number: 10091205)
Owner / Operator Contact Address
NO.4,5,6, JALAN TIRAM 5, TAMAN PERINDUSTRIAN TIRAM, ULU TIRAM, MY-01 81800, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

iSR'obot Biopsy Kit iSR'obot Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2024-07-23
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2024-07-23

Official Correspondent

KOH SIOH CHIAN

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

GLOBAL TECH PLASTIC INDUSTRY SDN BHD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3013844297 DANELIS MEDICAL LIMITED Rhayader Powys, GB
3010400865 WELL LEAD MEDICAL CO. LTD GUANGZHOU Guangdong, CN
3023245 SIEMENS MEDICAL SOLUTIONS USA, INC. ISSAQUAH, WA, US
3012411160 PROBO MEDICAL, INC. Fishers, IN, US
3016076141 HUMANSCAN CO., LTD Siheung-si Gyeonggi, KR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027381586. Last updated year: 2026. Please use registration number 3027381586 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.