Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043106343

FEI Number

3043106343

Entity Name

MAINIUSI INTELLIGENT MEDICAL TECHNOLOGY (SUZHOU) CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

5th Building, 2nd & 4th Floors, No. 892 Wusong Road, Guoxiang Subdistrict, Wuzhong Economic Development Zone, Suzhou Jiangsu 215100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mainiusi Intelligent Medical Technology (Suzhou) Co., Ltd. (Owner Number: 10094576)

Owner / Operator Contact Address

5th Building, 2nd & 4th Floors, No. 892 Wusong Road, Guoxiang Subdistrict, Wuzhong Economic Development Zone, Suzhou, CN-JS 215100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Saline Nasal Rinse Electrical Nasal Spray Irrigator Nasal Irrigation and Aspirator Device Nasal Irrigation Bottle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIP	Formulations, Balanced Salt Solutions	Hematology	Class 1	864.2875	2025-12-08
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2025-12-08
KFH	Antiserum, Positive Control, Blastomyces Dermatitidis	Microbiology	Class 2	866.3060	2026-04-15
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2025-12-08

Official Correspondent

Wang Wei

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Mainiusi Intelligent Medical Technology (Suzhou) Co., Ltd.

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 3043106343. Last updated year: 2026. Please use registration number 3043106343 when referencing this establishment in official correspondence.