Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011707784

FEI Number

3011707784

Entity Name

CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.

City/State/Country

Changshu Jiangsu, CN

Establishment Address

Building 2# Hongfeng Road & No.69-71 Hongdou Road, Baimao Industrial Park, Guli Town, Changshu Jiangsu 215532, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

ChangShu Rozer Sterilization Technology Co., Ltd. (Owner Number: 10049312)

Owner / Operator Contact Address

No.69-71 Hongdou Road, Baimao Industrial Park, Guli Town, Changshu, CN-JS 215532, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

(confidential) ENTERAL DELIVERY SET Urinemeters Disposable Polyp Traps Urine collector pediatric st; Urine Collector Sterile, Latex Free Urine collector pediatric st; Urine Collector Sterile, Latex Free Disposable Biopsy Forceps Irrigation Syringe, Urology; Syringe , Irrigation Stopper trauma dressing Wound Dressing Sterile Wound Dressing,Transparent Dressing,Carbon Fiber Dressing,ChitinDressing,Calcium Alginate Dressing,Foam Dressing (confidential) Urethral Catheterization Tray (w/ or w/o Catheter) Urethral Catheterization Tray (w/ or w/o Catheter) Disposable Injection Needle Speci-Cath kit Leg bag Urine Drainage Bag BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX CHAMBER/FLUTTER VALVE 2000 ML; BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX W/FLUTT (Confidential)Suture removal Tray Suture removal Tray Disposable Cold Snares 301435 BAC/VIR DEPTH FILTER CONTAINER, SPECIMEN, STERILE; Specimen Container, 4oz./120ccTransparent w/imprinted Opaque, Screw on Lid, Tamper Evident Click-n-closure Specimen Container Disposable Endoscope Valves Set A Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab Accuryn Monitoring System; Accuryn Sensing Urinary Catheter Bulb irrigation syringe 60cc ST; EAR BULB SYRINGE; Enteral irrigation syringe 60cc NS; Flat top piston irrigation syring Irrigation Syringe Ear/Ulcer Bulb Syringe, Sterile Yankauer With Suction Tubing ,Suction Catheter,Suction Catheter Kit,Suction Yankauer Urethral CATHETER, RETENTION TYPE, BALLOON Tracheostomy Care Kit Tracheostomy Kits Pediatric Urine bag Paste-on IV Start Kit; SHAVE PREP KIT; Skin Staple removal Kit; Staple removal Tray; Suture removal kit tyvek lid; Suture Removal Trach care kits 301-436,313-7043 PULMONAPY FUNCTION FILTER Disposable Retrieval Baskets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-05-12
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2015-05-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2018-11-25
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2015-05-12
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-10-31
FFH	Collector, Urine, Pediatric, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2015-05-12
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2018-11-25
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2021-12-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2017-10-19
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2015-05-12
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2018-11-25
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2015-05-12
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2015-05-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-05-12
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2018-11-25
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2024-04-09
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2015-05-12
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2015-05-12
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2018-11-25
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2023-08-03
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-06-15
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2024-06-15
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2024-06-15
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown	Class U	N/A	2024-06-15
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown	Class U	N/A	2021-04-13
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2021-04-13
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2021-04-13
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2015-05-12
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2017-10-19
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2015-05-11
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2021-12-04
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2015-05-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-05-12
EXI	Device, Paste-On For Incontinence, Sterile	Gastroenterology, Urology	Class 1	876.5250	2017-10-19
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-05-12
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2015-05-12
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2018-11-25

Official Correspondent

Gary Zhu

US Agent Details

Richard Cao Email: Richard0925@Gmail.Com Phone: (646) 7153488

Related Public Records

Same Entity

ChangShu Rozer Sterilization Technology 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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3025772870	ENTERAL ACCESS TECHNOLOGIES, LTD.	Caerwys Flintshire, GB
3015237508	ADVANCED MEDICAL BALLOONS GMBH	Waghaeusel Baden-Wurttemberg, DE
3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
1649518	Sterigenics US LLC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011707784. Last updated year: 2026. Please use registration number 3011707784 when referencing this establishment in official correspondence.