Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009460127

FEI Number

3009460127

Entity Name

ZONEFLY MEDICAL DEVICES CO., LTD.

City/State/Country

Danyang Jiangsu, CN

Establishment Address

LIANHU LAO ZHAODAISUO, LIANHU ROAD, Danyang Jiangsu 212300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

ZONEFLY MEDICAL DEVICES CO., LTD. (Owner Number: 10040910)

Owner / Operator Contact Address

LIANHU LAO ZHAODAISUO, LIANHU ROAD, Danyang, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WHEEL, POLISHING AGENT Respirator, surgical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2012-07-30
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2018-01-17
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2015-01-12
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-24
EJL	Bur, Dental	Dental	Class 1	872.3240	2012-06-01

Official Correspondent

Chaohui Jiang

US Agent Details

Macrae Carden Business: RAC CORPORATION Email: mcarden@raccorp.net Phone: (949) 4126689

Related Public Records

Same Entity

ZONEFLY MEDICAL DEVICES CO., LTD.

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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9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE
3011808221	NOVA IMPLANTS LTD	Or-Yehuda Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009460127. Last updated year: 2026. Please use registration number 3009460127 when referencing this establishment in official correspondence.