Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016752930

FEI Number

3016752930

Entity Name

ZEN LINEN INTERNATIONAL PRIVATE LIMITED.

City/State/Country

Chennai Tamil Nadu, IN

Establishment Address

Plot No. A48, A49 & A50, Phase-I,SEZ MEPZ, Tambaram, Chennai, Chennai Tamil Nadu 600045, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZEN LINEN INTERNATIONAL PRIVATE LIMITED. (Owner Number: 10095326)

Owner / Operator Contact Address

Plot No. A48, A49 & A50, Phase-I,SEZ MEPZ, Tambaram, Chennai, Chennai, IN-TN 600045, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DPT1624W-14

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2026-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

Binoy Joese Business: I3CGlobal US Inc Email: usagent@i3cglobal.us Phone: (304) 3001001

Related Public Records

Same Entity

ZEN LINEN INTERNATIONAL PRIVATE LIMITED.

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 3016752930. Last updated year: 2026. Please use registration number 3016752930 when referencing this establishment in official correspondence.