Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017202440

FEI Number

3017202440

Entity Name

UNICHELA PVT LTD - PANADURA

City/State/Country

Panadura Kalutara, LK

Establishment Address

No 124, Horana Road, Panadura Kalutara 12400, LK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Unichela Pvt Ltd - Panadura (Owner Number: 10085203)

Owner / Operator Contact Address

No 124, Horana Road, Panadura, LK-13 12400, LK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Therabody, Inc. SPEAX, Thinx For All Leaks Poise & Depends

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-06-30
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2023-03-20

Official Correspondent

Lasitha Nawarathna

US Agent Details

RAMESH FERNANDO Email: rameshfdo@masholdings.com Phone: (917) 2162552

Related Public Records

Same Entity

Unichela Pvt Ltd - Panadura

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 3017202440. Last updated year: 2026. Please use registration number 3017202440 when referencing this establishment in official correspondence.