MAZEN (BANGLADESH) INDUSTRIES LIMITED.

FDA Device Registration & Listing · Uttara Export Processing Zone Nilphamari, BD · Registration 3010397989

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
3010397989
FEI Number
3010397989
Entity Name
MAZEN (BANGLADESH) INDUSTRIES LIMITED.
City/State/Country
Uttara Export Processing Zone Nilphamari, BD
Establishment Address
SFB#2 (3rd Floor, Block-B, C, D & E),, Plot-02-21, Sector-03, Uttara Export Processing Zone Nilphamari 00000, BD
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Mazen (Bangladesh) Industries Limited. (Owner Number: 10043981)
Owner / Operator Contact Address
SFB#2 (3rd Floor, Block-B, C, D & E),, Plot-02-21, Sector-03, Uttara Export Processing Zone, BD-46 00000, BD
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQG Lens, Spectacle, Non-Custom (Prescription) Ophthalmic Class 1 886.5844 2013-04-13
HOI Spectacle, Magnifying Ophthalmic Class 1 886.5840 2013-04-13
HQY Sunglasses (Non-Prescription Including Photosensitive) Ophthalmic Class 1 886.5850 2013-04-13

Official Correspondent

Thomas Pang

US Agent Details

Thomas Pang Business: kapo optik Email: kapo_optik@yahoo.com Phone: (626) 2266699

Related Public Records

Same Entity

Mazen (Bangladesh) Industries Limited.
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
K940726 Jay-Y Enterprises Co., Inc. NONE-GENERIC 1994-04-11
K934837 Simon Marketing, Inc. SUNGLASSES 1993-12-08
K852902 Yours Enterprise Co., Ltd. METALLIC SUNGLASSES 1985-08-12
K970895 Custom Optical Frames, Inc. CUSTOM OPTICAL SUNGLASS FRAMES 1997-05-06
K853921 Winsburn Company , Ltd. ALL KINDS OF SUNGLASSES 1985-10-15

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1000428458 GKB OPHTHALMICS LIMITED - UNIT II North Goa Goa, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010397989. Last updated year: 2026. Please use registration number 3010397989 when referencing this establishment in official correspondence.
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