Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006636956

FEI Number

3006636956

Entity Name

CHANGZHOU ATOMIC HI-TECH RADIATION CO., LTD.

City/State/Country

CHANGZHOU, JIANGSU, CN

Establishment Address

ENVIRONMENTAL PROTECTION IND., ZONE, XIN BEI DISTRICT, CHANGZHOU, JIANGSU 213034, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

CHANGZHOU ATOMIC HI-TECH RADIATION CO., LTD. (Owner Number: 9103760)

Owner / Operator Contact Address

ENVIRONMENTAL PROTECTION IND., ZONE, XIN BEI DISTRICT, CHANGZHOU, JIANGSU, CN-NOTA 213034, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LUBRICANT PATIENT,STERILE LUBRICATING JELLY Graft releasing bell central blade Graft releasing bell external blade Disinfectant Tape and bandage ANTI FOG SOLUTION AND ACCESSORIES,ENDOSCOPY Sterile and Non-Sterile Ultrasound Gels;Media,Coupling,Ultrasound PACKING STRIP WITH IODOFORM Gauze Sponge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2026-05-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2026-01-26
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-09-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2015-09-19
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2026-05-28
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2026-05-28
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2025-12-14
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2007-07-02

Official Correspondent

ming lu

US Agent Details

Dennis Xu Business: PERFORMANCE INTERNATIONAL,CORP. Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

CHANGZHOU ATOMIC HI-TECH RADIATION 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
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

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2212018	PARKER LABORATORIES, INC.	FAIRFIELD, NJ, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006636956. Last updated year: 2026. Please use registration number 3006636956 when referencing this establishment in official correspondence.