BEUDAMED
    FDA Registration Active 🇨🇳 China

    CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.

    Reg #: 3011707784 · FEI: 3011707784 · Expires 2026
    View on FDA
    Products
    41
    Proprietary Names
    46
    Establishment Types
    1
    Classifications
    41

    Registration Details

    Registration Name
    CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
    Registration Number
    3011707784
    FEI Number
    3011707784
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 2# Hongfeng Road & No.69-71 Hongdou Road, Baimao Industrial Park, Guli Town
    City
    Changshu Jiangsu
    Country
    CN

    Owner / Operator

    Firm Name
    ChangShu Rozer Sterilization Technology Co., Ltd.
    Operator Number
    10049312
    Address
    No.69-71 Hongdou Road, Baimao Industrial Park, Guli Town
    City
    Changshu
    State
    Jiangsu
    Postal Code
    215532
    Country
    CN
    Correspondent
    Gary Zhu

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT
    Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
    Bottle, Collection, Vacuum KDQ
    Collector, Ostomy EXB
    Mask, Surgical FXX
    Collector, Urine, Pediatric, For Indwelling Catheter FFH
    Forceps, Biopsy, Non-Electric FCL
    System, Irrigation, Urological LJH
    Dressing, Wound, Occlusive NAD
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Tray, Surgical, Instrument FSM
    Snare, Non-Electrical FGX
    Catheter Care Tray OHR
    Filter, Bacterial, Breathing-Circuit CAH
    Container, Specimen, Sterile FMH
    Endoscope Channel Accessory ODC
    Catheter, Straight EZD
    Catheter, Retention Type, Balloon EZL
    Uroflowmeter EXY
    Medical Device Data System OUG
    Intra-Abdominal Pressure Monitoring Device PHU
    Syringe, Irrigating (Non Dental) KYZ
    Excavator, Ear JYH
    Catheter And Tip, Suction JOL
    General Surgery Tray LRO
    Kit, Surgical Instrument, Disposable KDD
    Device, Paste-On For Incontinence, Sterile EXI
    Spirometer, Diagnostic BZG
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Endoscopic Bite Block MNK
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Dressing, Compression MHW
    Connector, Catheter GCD
    Needle, Aspiration And Injection, Disposable GAA
    Accessories, Catheter KGZ
    Tube, Aspirating, Flexible, Connecting BYY
    Sheet, Burn FPY
    Fiber, Medical, Absorbent FRL

    Proprietary Names

    (confidential) ENTERAL DELIVERY SET Urinemeters Disposable Polyp Traps 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 Disposable Bite Blocks (confidential)APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED-MEDLINE Blood stopper,Dyna-Stopper Trauma Dressing, Sterile (confidential)5-IN-1 Connector NDL, BLUNT;NDL, BLUNT, FILTER;SYRINGE,NDL; Safety Needle Disposable Spray Catheters Suction conneting tube; Suction Tubing 1/4; Suction Tubing 3/16; TUBE, ASPIRATING, FLEXIBLE, CONNECTING Suction conneting tube Burn blanket

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)