Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026326475

FEI Number

3026326475

Entity Name

CHANGZHOU OU NUO MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

Factory Building, 4th Floor, Building 12, No.8, Lanxiang Road, West Taihu Science and Technology Industrial Park, Changzhou City Jiangsu 213100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou Ou Nuo Medical Equipment Co., Ltd. (Owner Number: 10087154)

Owner / Operator Contact Address

Factory Building, 4th Floor, Building 12, No.8, Lanxiang Road, West Taihu Science and Technology Industrial Park, Changzhou City, CN-JS 213100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MUL076 Lux, C050 Pro. T076RS120N, T088RS120N, T100RS120N, T040MS120N, T050MS120N, T063MS120N, T076MS120N, T088MS120N, T100MS120N, T040, T050, Dental Sheet/Dental Roll: T040RC125N, T050RC125N, T063RC125N, T076RC125N, T088RC125N, T100RC125N, T040MC125N, C150, C200, MUL063, MUL076, MUL100, MUL150, MUL175, MUL200, MUL250, MUL300, MUL350, MUL400, MUL450, MUL500, MUL076 Pro, T063, T076, T088, T100, T150, T200, P040, P050, P063, P076, P088, P100, P150, P200, C040, C050, C063, C076, C088, C100, T050MC125N, T063MC125N, T076MC125N, T088MC125N, T100MC125N, T040RS125N, T050RS125N, T063RS125N, T076RS125N, T088RS125N, T100RS125N, T040MS125N, T050MS125N, T063MS125N, T076MS125N, T088MS125N, T100MS125N, T040RS120N, T050RS120N, T063RS120N,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2023-01-18

Official Correspondent

Xuelian Jiang

US Agent Details

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

Related Public Records

Same Entity

Changzhou Ou Nuo Medical Equipment Co., Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3010622180	MEGA-PHYSIK Ges. fuer physikalische Messtechnik mbh Co KG	Rastatt Baden-Wurttemberg, DE
3009509745	DENT A PHARM PRODUKTIONSGESELLSCHAFT MBH	Barmstedt Schleswig-Holstein, DE
2411056	BUFFALO DENTAL MFG. CO., INC.	SYOSSET, NY, US
1417846	FRICKE DENTAL MFG. CO.	Streamwood, IL, US
3016447764	DSI DENTAL SOLUTIONS LTD	Ashdod Southern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026326475. Last updated year: 2026. Please use registration number 3026326475 when referencing this establishment in official correspondence.