Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008850249

FEI Number

3008850249

Entity Name

CHANGZHOU DSB MEDICAL CO., LTD

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

No. 355 Longjin Road, , Changzhou Economic Development Zone, Jiangsu Province, Changzhou City Jiangsu 213025, CN

Establishment Type(s)

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

Owner / Operator

Changzhou DSB Medical Co., Ltd (Owner Number: 10035099)

Owner / Operator Contact Address

No. 355 Longjin Road,, Changzhou Economic Development Zone, Changzhou City, CN-JS 213025, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211042

PMA Number

N/A

All Registered Proprietary Names

CultureSafe DSB specimen container tube and cap Convenience Bag Disposable meidical protective mask Moleculight Drape FACE MASK DSB Urine Bag Urine Specimen Collection Bag DSB extension tubing irrigation system Disposable procedural Ear-loop Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2023-04-17
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2011-02-03
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2016-01-19
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2021-12-09
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2011-12-22
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-04
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2016-09-27
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-14
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-09-20
FOC	Bag, Urine Collection, Newborn	Gastroenterology, Urology	Class 2	876.5250	2014-05-29
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2016-01-19
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-03

Official Correspondent

Walter Zhang

US Agent Details

Dinesh Shah Business: International Medsurg Connection Inc. Email: dineshshah@intlmedsurg.com Phone: (847) 6199926

Related Public Records

Same Entity

Changzhou DSB Medical 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K911329	C.R. Bard, Inc.	BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE	1991-05-28

Similar Registrations

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3042585783	NOVASCOPE BIOCHIPS INC.	Boston, MA, US
3009756327	Synergy Health Ede BV	Ede Gelderland, NL
3014642322	PRECISION CONVERTING SOLUTIONS LTD.	Khlong Luang Pathum Thani, TH
8010096	OXOID, LTD.	BASINGSTOKE, HAMPSHIRE, GB
1423625	INTL. MEDSURG CONNECTION, INC.	Schaumburg, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008850249. Last updated year: 2026. Please use registration number 3008850249 when referencing this establishment in official correspondence.