FITSON SDN BHD

FDA Device Registration & Listing · Senai Johor, MY · Registration 3004957421

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
3004957421
FEI Number
3004957421
Entity Name
FITSON SDN BHD
City/State/Country
Senai Johor, MY
Establishment Address
19 Jalan I-Park SAC 3, Taman Perindustrian I-Park SAC, Senai Johor 81400, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Fitson Sdn Bhd (Owner Number: 10029016)
Owner / Operator Contact Address
37 Jalan Permas 9/12,, Bandar Baru Permas Jaya, Johor Bahru, MY-01 81750, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pigeon Singapore Pte Ltd Nurnberg Gummi Babyartikel GmbH & Co. Kg Allegre Puericulture SAS Laboratoires Polive Hegen Pte Ltd Hegen Pte Ltd

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MEF Ring, Teething, Non-Fluid Filled Dental Class 1 872.5550 2009-05-27
HGY Pump, Breast, Non-Powered Obstetrics/Gynecology Class 1 884.5150 2022-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

Julia Hilario Email: Julia.Hilario@hegen.com Phone: (650) 2489721

Related Public Records

Same Entity

Fitson 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 3004957421. Last updated year: 2026. Please use registration number 3004957421 when referencing this establishment in official correspondence.
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