iHealth Manufacturing Inc

FDA Device Registration & Listing · Irwindale, CA, US · Registration 3023947183

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
3023947183
FEI Number
3023947183
Entity Name
iHealth Manufacturing Inc
City/State/Country
Irwindale, CA, US
Establishment Address
15715 Arrow Hwy, Irwindale, CA 91706, Irwindale, CA 91706, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
iHealth labs Inc (Owner Number: 10078949)
Owner / Operator Contact Address
880 W Maude Ave, Sunnyvale, CA 94085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2022-09-10

Official Correspondent

Yange Wang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iHealth labs Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008787503 iHealth Labs, Inc. Sunnyvale, CA, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2023 Jiangsu Well Biotech Co., Ltd. No N
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023947183. Last updated year: 2026. Please use registration number 3023947183 when referencing this establishment in official correspondence.
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