Rozer Sterilization Technology Shuyang Company Limited
Registered establishment in Shuyang, Jiangsu, China. 33 device types.
Rozer Sterilization Technology Shuyang Company Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Sheet, Burn, Excavator, Ear and 31 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | ROZER STERILIZATION TECHNOLOGY SHUYANG COMPANY LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018116884 |
| FEI number | 3018116884 |
| Establishment type | Contract manufacturer, Contract steriliser |
Location
| City | Shuyang |
|---|---|
| Province | Jiangsu |
| Address | No.32 Jinhua Rd. |
| Postal code | 223600 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | Catheter Accessories | 2020 | 33 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | SUCTION APPARATUS, Reservoir Bulb Silicon | 2020 | 58 |
| Bottle, Collection, Vacuum | Class 2 | Collection Bottle, | 2020 | 88 |
| Catheter, Straight | Class 2 | Straight foley catheter | 2020 | 21 |
| Collector, Ostomy | Class 1 | Ostomy bag, Ostomy collector | 2020 | 18 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | URINE collector (AND ACCESSORIES) FOR INDWELLING CATHETER | 2020 | 51 |
| Collector, Urine, Pediatric, For Indwelling Catheter | Class 2 | Pediatrick Uine collector | 2020 | 11 |
| Container, Specimen, Sterile | Class 1 | Specimen Container, Urine specimen container | 2020 | 79 |
| Device, Paste-On For Incontinence, Sterile | Class 1 | Paste-ON FOR Incontinence | 2020 | 12 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class 2 | 2020 | 19 | |
| Dislodger, Stone, Basket, Ureteral, Metal | Class 2 | Stone Dislodger Basket, | 2020 | 21 |
| Dressing, Compression | Class 1 | Compression Dressing | 2020 | 87 |
| Dressing, Wound, Occlusive | Class 1 | Occlusive wound Dressing, | 2020 | 183 |
| Endoscope Channel Accessory | Class 2 | 2020 | 21 | |
| Endoscopic Bite Block | Class 1 | Endoscopic bite block | 2020 | 44 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | endoscopic injection needle, gastroenterology-urology | 2020 | 23 |
| Excavator, Ear | Class 1 | EAR Excavator, | 2020 | 6 |
| Fiber, Medical, Absorbent | Class 1 | Medical Absorbent Fiber, | 2020 | 172 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | bacterial filter for breathing circuit | 2020 | 15 |
| Forceps, Biopsy, Non-Electric | Class 1 | Biopsy Forceps | 2020 | 44 |
| General Surgery Tray | Class 2 | General surgery tray | 2020 | 24 |
| Kit, Surgical Instrument, Disposable | Class 1 | Surgical Kit, surgical instrument kit, surgical convenient kit | 2020 | 67 |
| Mask, Surgical | Class 2 | Surgical Mask | 2020 | 125 |
| Needle, Aspiration And Injection, Disposable | Class 1 | Aspiration AND Injection Needle, Disposable | 2020 | 37 |
| Sheet, Burn | Class 1 | Burn Sheet | 2020 | 20 |
| Snare, Non-Electrical | Class 1 | Snare, NON-Electrical | 2020 | 19 |
| Spirometer, Diagnostic | Class 2 | Diagnostic Spirometer, | 2020 | 10 |
| Syringe, Irrigating (Non Dental) | Class 1 | Irrigation syringe, piston, ringe, bulb | 2020 | 110 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class 1 | URINE DRAINAGE CLOSED system | 2020 | 23 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class 2 | sterile urethral catheterization, with or without catheter | 2020 | 11 |
| Tray, Surgical, Instrument | Class 1 | Surgical tray, Surgical instrument Tray | 2020 | 105 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | extension tube, connection tube | 2020 | 51 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | gastrointestinal tubes (and accessories) | 2020 | 25 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Ethylene oxide sterilization services |
| Certifications | ISO13485-2016, ISO11135-2014, FDA, FMA Japan |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Conod Medical Shuyang Co., Ltd. | 22 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | 18 |
| Jiangsu Hongxin Medical Technology Co., Ltd. | 7 |
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.
The manufacturer named here can complete this record.