Changshu Rozer Sterilization Technology Co., Ltd.
Registered establishment in Changshu, Jiangsu, China. 43 device types.
Changshu Rozer Sterilization Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Sheet, Burn, Uroflowmeter and 41 other device types. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011707784 |
| FEI number | 3011707784 |
| Establishment type | Contract manufacturer, Contract steriliser |
Location
| City | Changshu |
|---|---|
| Province | Jiangsu |
| Address | Building 2# Hongfeng Road & No.69-71 Hongdou Road |
| Postal code | 215532 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | Disposable Spray Catheters | 2018 | 33 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | (confidential)APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED-MEDLINE | 2015 | 58 |
| Bottle, Collection, Vacuum | Class 2 | Disposable Polyp Traps | 2018 | 88 |
| Catheter And Tip, Suction | Class 2 | Yankauer With Suction Tubing ,Suction Catheter,Suction Catheter Kit,Suction Yankauer | 2015 | 70 |
| Catheter Care Tray | Class 2 | 2024 | 12 | |
| Catheter, Retention Type, Balloon | Class 2 | Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab, Accuryn Monitoring System; Accuryn Sensing Urinary Catheter, Urethral CATHETER, RETENTION TYPE, BALLOON | 2021 | 17 |
| Catheter, Straight | Class 2 | 2023 | 21 | |
| Collector, Ostomy | Class 1 | Urine collector pediatric st; Urine Collector Sterile, Latex Free | 2015 | 18 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | BAG, Urinary Drain, Vinyl LF Anit-Reflux Chamber/Flutter Valve 2000 ML; BAG, Urinary Drain, Vinyl LF Anit-Reflux W/Flutt | 2015 | 51 |
| Collector, Urine, Pediatric, For Indwelling Catheter | Class 2 | Urine collector pediatric st; Urine Collector Sterile, Latex Free | 2015 | 11 |
| Connector, Catheter | Class 1 | (confidential)5-IN-1 Connector | 2015 | 15 |
| Container, Specimen, Sterile | Class 1 | CONTAINER, SPECIMEN, STERILE; Specimen Container, 4oz./120ccTransparent w/imprinted Opaque, Screw on Lid, Tamper Evident, Click-n-closure Specimen Container | 2015 | 79 |
| Device, Paste-On For Incontinence, Sterile | Class 1 | Pediatric Urine bag Paste-on | 2017 | 12 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class 2 | Urinemeters | 2015 | 19 |
| Dislodger, Stone, Basket, Ureteral, Metal | Class 2 | Disposable Retrieval Baskets | 2018 | 21 |
| Dressing, Compression | Class 1 | Blood stopper,Dyna-Stopper Trauma Dressing, Sterile | 2017 | 87 |
| Dressing, Wound, Occlusive | Class 1 | Stopper trauma dressing, Sterile Wound Dressing,Transparent Dressing,Carbon Fiber Dressing,ChitinDressing,Calcium Alginate Dressing,Foam Dressing, Wound Dressing | 2017 | 183 |
| Endoscope Channel Accessory | Class 2 | Disposable Endoscope Valves Set A | 2018 | 21 |
| Endoscopic Bite Block | Class 1 | Disposable Bite Blocks | 2018 | 44 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | Disposable Injection Needle | 2018 | 23 |
| Evacuator, Bladder, Manually Operated | Class 1 | 2026 | 3 | |
| Excavator, Ear | Class 1 | Ear/Ulcer Bulb Syringe, Sterile | 2017 | 6 |
| Fiber, Medical, Absorbent | Class 1 | 2019 | 172 | |
| Filter, Bacterial, Breathing-Circuit | Class 2 | 301435 BAC/VIR Depth Filter | 2015 | 15 |
| Forceps, Biopsy, Non-Electric | Class 1 | Disposable Biopsy Forceps | 2018 | 44 |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | 2026 | 17 | |
| General Surgery Tray | Class 2 | Tracheostomy Care Kit, Tracheostomy Kits | 2015 | 24 |
| Intra-Abdominal Pressure Monitoring Device | Class U | Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab, Accuryn Monitoring System; Accuryn Sensing Urinary Catheter | 2021 | 4 |
| Kit, Surgical Instrument, Disposable | Class 1 | Tracheostomy Care Kit, Tracheostomy Kits, IV Start Kit; SHAVE PREP KIT; Skin Staple removal Kit; Staple removal Tray; Suture removal kit tyvek lid; Suture Removal, Trach care kits | 2015 | 67 |
| Mask, Surgical | Class 2 | 2020 | 125 | |
| Medical Device Data System | Class 1 | Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab | 2024 | 11 |
| Needle, Aspiration And Injection, Disposable | Class 1 | NDL, BLUNT;NDL, BLUNT, FILTER;SYRINGE,NDL; Safety Needle | 2019 | 37 |
| Sheet, Burn | Class 1 | Burn blanket | 2017 | 20 |
| Snare, Non-Electrical | Class 1 | Disposable Cold Snares | 2018 | 19 |
| Spirometer, Diagnostic | Class 2 | 301-436,313-7043 Pulmonapy Function Filter | 2015 | 10 |
| Syringe, Irrigating (Non Dental) | Class 1 | Bulb irrigation syringe 60cc ST; EAR BULB SYRINGE; Enteral irrigation syringe 60cc NS; Flat top piston irrigation syring, Irrigation Syringe | 2015 | 110 |
| System, Irrigation, Urological | Class 2 | Irrigation Syringe, Urology; Syringe , Irrigation | 2021 | 8 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class 1 | Leg bag, Speci-Cath kit, Urine Drainage Bag | 2015 | 23 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class 2 | (confidential) Urethral Catheterization Tray (w/ or w/o Catheter), Urethral Catheterization Tray (w/ or w/o Catheter) | 2015 | 11 |
| Tray, Surgical, Instrument | Class 1 | (Confidential)Suture removal Tray, Suture removal Tray | 2015 | 105 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Suction conneting tube; Suction Tubing 1/4; Suction Tubing 3/16; TUBE, ASPIRATING, FLEXIBLE, CONNECTING, Suction conneting tube | 2015 | 51 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | (confidential) ENTERAL DELIVERY SET | 2015 | 25 |
| Uroflowmeter | Class 2 | Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab, Accuryn Monitoring System; Accuryn Sensing Urinary Catheter | 2021 | 7 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Ethylene oxide sterilization services |
| Certifications | FDA, TÜV SÜD, Japan Ministry of Health |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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