Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022585053

FEI Number

3022585053

Entity Name

ZHEJIANG FOMOS MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

Floor 3 Block 21 No.205 Guangyuan Road Jiangbei District, Ningbo Zhejiang 315033, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Zhejiang Fomos Medical Technology Co., Ltd. (Owner Number: 10094549)

Owner / Operator Contact Address

Floor 3 Block 21 No.205 Guangyuan Road Jiangbei District, Ningbo, CN-ZJ 315033, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Water distiller Ultrasonic cleaner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2025-12-06
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-12-06

Official Correspondent

CHUNPING FANG

US Agent Details

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

Related Public Records

Same Entity

Zhejiang Fomos Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022585053. Last updated year: 2026. Please use registration number 3022585053 when referencing this establishment in official correspondence.