CONCHA INC.

FDA Device Registration & Listing · San Mateo, CA, US · Registration 3030627827

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
3030627827
FEI Number
3030627827
Entity Name
CONCHA INC.
City/State/Country
San Mateo, CA, US
Establishment Address
55 East 3rd Ave, San Mateo, CA 94401, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Concha Inc. (Owner Number: 10090365)
Owner / Operator Contact Address
55 East 3rd Ave, San Mateo, CA 94401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233747
PMA Number
N/A

All Registered Proprietary Names

Concha Sol Hearing Aids (CL-1001)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter Ear, Nose, Throat Class 2 874.3325 2024-03-18
QDD Self-Fitting Air-Conduction Hearing Aid, Prescription Ear, Nose, Throat Class 2 874.3325 2024-03-18

Official Correspondent

Amy Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Concha Inc.
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 3030627827. Last updated year: 2026. Please use registration number 3030627827 when referencing this establishment in official correspondence.
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