Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017899097

FEI Number

3017899097

Entity Name

UNICHELA ( PVT) LTD

City/State/Country

Koggala Galle, LK

Establishment Address

Export Processing Zone Koggala Habaraduwa, Koggala Galle 80630, LK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Unichela ( Pvt) Ltd - Koggala Division (Owner Number: 10079625)

Owner / Operator Contact Address

Export Processing Zone Koggala Habaraduwa, Koggala, LK-31 80630, LK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Poise & Depends SPEAX Thinx For All Leaks Here We Flo Thinx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2024-09-10

Official Correspondent

Lasitha Nawarathna

US Agent Details

Ramesh Fernando Email: rameshfdo@masholdings.com Phone: (917) 2162552

Related Public Records

Same Entity

Unichela ( Pvt) Ltd - Koggala Division

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 3017899097. Last updated year: 2026. Please use registration number 3017899097 when referencing this establishment in official correspondence.