Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018116884

FEI Number

3018116884

Entity Name

ROZER STERILIZATION TECHNOLOGY SHUYANG COMPANY LIMITED

City/State/Country

Shuyang Jiangsu, CN

Establishment Address

No.32 Jinhua Rd., Shuyang Jiangsu 223600, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Rozer Sterilization Technology Shuyang Company Limited (Owner Number: 10079290)

Owner / Operator Contact Address

No.32 Jinhua Rd.,, Shuyang, CN-JS 223600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

sterile urethral catheterization, with or without catheter URINE DRAINAGE CLOSED system STONE DISLODGER BASKET, Occlusive wound Dressing, Ostomy bag, Ostomy collector Straight foley catheter COMPRESSION DRESSING DIAGNOSTIC SPIROMETER, PASTE-ON FOR INCONTINENCE Surgical tray, Surgical instrument Tray CATHETER ACCESSORIES EAR EXCAVATOR, Surgical Kit, surgical instrument kit, surgical convenient kit Endoscopic bite block MEDICAL ABSORBENT FIBER, SNARE, NON-ELECTRICAL COLLECTION BOTTLE, Surgical Mask BIOPSY FORCEPS endoscopic injection needle, gastroenterology-urology bacterial filter for breathing circuit gastrointestinal tubes (and accessories) SUCTION APPARATUS, Reservoir Bulb Silicon Burn Sheet URINE collector (AND ACCESSORIES) FOR INDWELLING CATHETER General surgery tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2020-11-29
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-11-29
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2020-11-29
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2020-11-29
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-11-29
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-11-29
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2020-11-29
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2020-11-29
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2020-11-29
EXI	Device, Paste-On For Incontinence, Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-11-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-11-29
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-11-29
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2020-11-29
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-11-29
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2020-11-29
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2020-11-29
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2020-11-29
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-11-29
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2020-11-29
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-11-29
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2020-11-29
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-11-29
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2020-11-29
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2020-11-29
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2020-11-29
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2020-11-29
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2020-11-29
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2020-11-29

Official Correspondent

Gary ZHU

US Agent Details

Richard Cao Email: richard0925@gmail.com Phone: (646) 7153488

Related Public Records

Same Entity

Rozer Sterilization Technology Shuyang Company Limited

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
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
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3011987967	ConvaTec, Inc.	Greensboro, NC, US
3005669815	AMSINO MEDICAL (KUNSHAN) CO., LTD.	KUNSHAN CITY Jiangsu, CN
3017961114	SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD.	Suzhou Jiangsu, CN
3015176887	GREYSTONE MEDICAL, LLC	Waterford, MI, US
3006082230	C.R. BARD, INC.	MADISON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018116884. Last updated year: 2026. Please use registration number 3018116884 when referencing this establishment in official correspondence.