DURIO PPE SDN. BHD.

FDA Device Registration & Listing · Johor Bahru, MY · Registration 3017598017

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
3017598017
FEI Number
3017598017
Entity Name
DURIO PPE SDN. BHD.
City/State/Country
Johor Bahru, MY
Establishment Address
16, Jalan Temenggong, Johor Bahru 81100, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Durio PPE Sdn. Bhd. (Owner Number: 10077777)
Owner / Operator Contact Address
16, Jalan Temenggong, Johor Bahru, MY-01 81100, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CRANBERRY DURIO DURIO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKR Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Unknown Class N N/A 2020-09-21
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-10-26

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Durio PPE Sdn. Bhd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017598017. Last updated year: 2026. Please use registration number 3017598017 when referencing this establishment in official correspondence.
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