Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008788129

FEI Number

3008788129

Entity Name

GUANGZHOU CLEAN MEDICAL PRODUCTS MANUFACTURING CORP

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No.163 Meidu Road, Chengjiao,, Conghua District, Guangzhou Guangdong 510900, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Guangzhou Clean Medical Products Manufacturing Corp (Owner Number: 10054627)

Owner / Operator Contact Address

No.163 Meidu Road, Chengjiao,, Conghua District, Guangzhou, CN-GD 510900, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bone Cement Mixing System; Bone Cement Mixing System Accessory: Trumpet adapter; PALABOWL®; Large Nozzle; Slim Nozzle Disposable Electronically Pulsed Lavage Suction Apparatus; palaJet® Disposable Pulse Lavage System; Fan Spray Nozzle; Splash Guard Femoral Nozzle; Femoral Brush Nozzle; Shower Spray Nozzle (Spine Nozzle); Shoulder Nozzle; Large Splash Shield; Disposable Irrigation Bag PALAGUN® Bone Cement Mixing System Disposable Cement Gun, Bone Cement Gun COPAL® exchange G Trial Sets; COPAL® knee mould Trials S US; COPAL® knee mould Trials M US; COPAL® knee mould Trials L US

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2017-04-10
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2017-04-10
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-03-06
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2017-12-03
HWT	Template	Orthopedic	Class 1	888.4800	2022-05-12

Official Correspondent

David Zhong

US Agent Details

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

Related Public Records

Same Entity

Guangzhou Clean Medical Products Manufacturing Corp

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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008788129. Last updated year: 2026. Please use registration number 3008788129 when referencing this establishment in official correspondence.