Changshu Rozer Sterilization Technology Co L T D

FDA Filings

This page includes the latest FDA filings for Changshu Rozer Sterilization Technology Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011707784
FEI Number3011707784
NameCHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Owner & OperatorChangShu Rozer Sterilization Technology Co., Ltd.
Contact AddressBuilding 2#, Hongfeng Rd., Baimao Industrial Zone, Guli Town
Changshu CN-32 Jiangsu 215532 CN
Official Correspondent
  • Gary Zhu
  • 086-512-52305272-x
US Agent
Importing Logistics Registration
ImporterPENTAX Medical Compnay
Address3 Paragon Drive Montvale
Montvale, NJ 07645 UNITED STATES
Importer TypeRetailer
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressBuilding 2#, Hongfeng Rd., Baimao Industrial Zone, Guli Town
Changshu Jiangsu, 215532 CN
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)



FDA Filings

Device
Company
DeviceDate
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
NDL, BLUNT;NDL, BLUNT, FILTER;SYRINGE,NDL; Safety Needle2019-07-27
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Disposable Endoscope Valves Set A2018-11-25
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Disposable Injection Needle2018-11-25
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Disposable Bite Blocks2018-11-25
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Disposable Spray Catheters2018-11-25
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Disposable Polyp Traps2018-11-25
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Disposable Cold Snares2018-11-25
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Disposable Retrieval Baskets2018-11-25
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Disposable Biopsy Forceps2018-11-25
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Wound Dressing2017-10-19
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Stopper trauma dressing2017-10-19
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Sterile Wound Dressing,Transparent Dressing,Carbon Fiber Dressing,ChitinDressing,Calcium Alginate Dressing,Foam Dressing2017-10-19
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Blood stopper,Dyna-Stopper Trauma Dressing, Sterile2017-10-19
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Ear/Ulcer Bulb Syringe, Sterile2017-10-19
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Burn blanket2017-10-19
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Pediatric Urine bag Paste-on2017-10-19
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
(Confidential) PVC urethral catheter2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
(confidential) ENTERAL DELIVERY SET2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Urethral Catheterization Tray (w/ or w/o Catheter)2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
(confidential) Urethral Catheterization Tray (w/ or w/o Catheter)2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Tracheostomy Kits2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Tracheostomy Care Kit2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Tracheostomy Kits2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Tracheostomy Care Kit2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
301-436,313-7043 PULMONAPY FUNCTION FILTER2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
301435 BAC/VIR DEPTH FILTER2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Irrigation Syringe2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Bulb irrigation syringe 60cc ST; EAR BULB SYRINGE; Enteral irrigation syringe 60cc NS; Flat top piston irrigation syring2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX CHAMBER/FLUTTER VALVE 2000 ML; BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX W/FLUTT2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Trach care kits2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
IV Start Kit; SHAVE PREP KIT; Skin Staple removal Kit; Staple removal Tray; Suture removal kit tyvek lid; Suture Removal2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
(confidential)APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED-MEDLINE2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
(confidential)5-IN-1 Connector2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Suture removal Tray2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
(Confidential)Suture removal Tray2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Click-n-closure Specimen Container2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
CONTAINER, SPECIMEN, STERILE; Specimen Container, 4oz./120ccTransparent w/imprinted Opaque, Screw on Lid, Tamper Evident2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Urine collector pediatric st; Urine Collector Sterile, Latex Free2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Urinemeters2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Urine Drainage Bag2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Speci-Cath kit2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Leg bag2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Urine collector pediatric st; Urine Collector Sterile, Latex Free2015-05-12
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Yankauer With Suction Tubing ,Suction Catheter,Suction Catheter Kit,Suction Yankauer2015-05-11
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Suction conneting tube2015-05-11
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
Suction conneting tube; Suction Tubing 1/4; Suction Tubing 3/16; TUBE, ASPIRATING, FLEXIBLE, CONNECTING2015-05-11

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