ISUNIYE LLC

FDA Device Registration & Listing · Milpitas, CA, US · Registration 3029745674

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
3029745674
FEI Number
3029745674
Entity Name
ISUNIYE LLC
City/State/Country
Milpitas, CA, US
Establishment Address
1551 McCarthy Blvd, Suite 102, Milpitas, CA 95035, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
iSuniye LLC (Owner Number: 10058665)
Owner / Operator Contact Address
1551 MCCARTHY BLVD, STE 102, Milpitas, CA 95035, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Koel OTC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription Ear, Nose, Throat Class 2 874.3305 2018-10-18
QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Ear, Nose, Throat Class 2 874.3305 2025-02-18

Official Correspondent

Nilesh Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iSuniye LLC
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 3029745674. Last updated year: 2026. Please use registration number 3029745674 when referencing this establishment in official correspondence.
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