Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044828933

FEI Number

3044828933

Entity Name

OSEL DEVICES LIMITED

City/State/Country

Gautam Budh Nagar Uttar Pradesh, IN

Establishment Address

First Floor, Plot No-03, Signature Tower, Tower No 3, Knowledge Park 3, Greater Noida, Gautam Budh Nagar Uttar Pradesh 201308, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSEL DEVICES LIMITED (Owner Number: 10095506)

Owner / Operator Contact Address

First Floor, Plot No-03, Signature Tower, Tower No 3, Knowledge Park 3, Greater Noida, Gautam Budh Nagar, IN-UP 201308, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BTE60T,BTE50T,BTEST508CP,BTEST458CP,BTESTP608CP,BTESTPP658CP,BTESTG4516CP,BTEST5016CP,BTESTP6016CP,BTESTPP6516CP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2026-03-22

Official Correspondent

Yogesh Joshi

US Agent Details

Mounika Gudeppu Email: Mounika@qualentraglobal.com Phone: (224) 2243696

Related Public Records

Same Entity

OSEL DEVICES 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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044828933. Last updated year: 2026. Please use registration number 3044828933 when referencing this establishment in official correspondence.