Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010186069

FEI Number

3010186069

Entity Name

Zhangzhou iHastek Inc.

City/State/Country

Zhangzhou City Fujian, CN

Establishment Address

No. 10 Jinda Road, Wanlida Industry Zone, Zhangzhou City Fujian 363000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhangzhou iHastek Inc. (Owner Number: 10042566)

Owner / Operator Contact Address

No. 10 Jinda Road, Wanlida Industry Zone, Zhangzhou City, CN-FJ 363000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Holmes humidifier Claritin humidifier Sunbeam humidifier Bionaire humidifier Therapure humidifier HoMedics humidifier Mainstays humidifier, HU00-19013B, HU00-19054, H12-01 Humidifier KN95 masks/Non-powered air-purifying particle masks/Disposable face masks, YW9501,YW9502 KN95 Masks/Non-powered air-purifying particle masks/Disposable face masks, YW9501, YW9502, KN95 Disposable Mask, KN95 Mask, Non-powered air-purifying particle mask, YW9501, YW9502

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2012-12-07
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-26
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-14
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Zhangzhou iHastek Inc.

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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3011919098	NINGBO JUST SOON INDUSTRIAL LIMITED	Ningbo Zhejiang, CN
3004264602	SHANGHAI FOREIGN TRADE ENTERPRISES PUDONG CO., LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010186069. Last updated year: 2026. Please use registration number 3010186069 when referencing this establishment in official correspondence.