ZARAPAK SDN. BHD.

FDA Device Registration & Listing · Perak, MY · Registration 3017771197

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
3017771197
FEI Number
3017771197
Entity Name
ZARAPAK SDN. BHD.
City/State/Country
Perak, MY
Establishment Address
Lot 19786, Jalan Perusahaan 6, Kawasan Perindustrian Kamunting, 34600, Kamunting, Perak 34600, MY
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ZARAPAK SDN. BHD. (Owner Number: 10077995)
Owner / Operator Contact Address
Lot 19786, Jalan Perusahaan 6, Kawasan Perindustrian Kamunting, 34600, Kamunting, Perak, MY-NOTA 34600, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ZARAPAK

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2020-10-07

Official Correspondent

No official correspondent registered.

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

ZARAPAK 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 3017771197. Last updated year: 2026. Please use registration number 3017771197 when referencing this establishment in official correspondence.
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