Changzhou DSB Medical Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 16 device types, 1 clearance.
Changzhou DSB Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cover, Cast, Basin, Emesis and 14 other device types. Its earliest product listing with the FDA dates from 2011.
16device types registered with the FDA
1510(k) clearance
Registration
| Registered name | CHANGZHOU DSB MEDICAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008850249 |
| FEI number | 3008850249 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 常州)医疗用品股份有限公司 |
|---|---|
| Source | Qianzhan company data |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 355 Longjin Road, , Changzhou Economic Development Zone |
| Postal code | 213025 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Catheter | Class 1 | 2013 | 33 | |
| Accessory, Surgical Apparel | Class 1 | Disposable meidical protective mask | 2020 | 439 |
| Bag, Urine Collection, Newborn | Class 2 | Urine Specimen Collection Bag | 2014 | 1 |
| Basin, Emesis | Class 1 | Convenience Bag | 2021 | 65 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urinary Drainage Bag | 2026 | 51 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | DSB specimen container tube and cap | 2016 | 51 |
| Cover, Barrier, Protective | Class 2 | 2011 | 15 | |
| Cover, Cast | Class 1 | Moleculight Drape | 2016 | 31 |
| Device, General Purpose, Microbiology, Diagnostic | Class 1 | CultureSafe | 2023 | 7 |
| Device, Incontinence, Urosheath Type, Non-Sterile | Class 1 | Male External Catheter | 2023 | 13 |
| Injector And Syringe, Angiographic | Class 2 | 2013 | 15 | |
| Mask, Scavenging | Class 1 | Disposable Face Mask | 2020 | 158 |
| Mask, Surgical | Class 2 | Face Mask, Disposable procedural Ear-loop Face Mask | 2020 | 125 |
| Micro Pipette | Class 1 | 2011 | 29 | |
| System, Irrigation, Urological | Class 2 | DSB extension tubing irrigation system | 2016 | 8 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | Class 1 | DSB Urine Bag | 2013 | 13 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211042 | 2021-07-15 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | drug delivery devices, incontinence care products, medical consumables, biological chips, fecal management systems |
| Certifications | CE (EU MDR Class IIa), FDA, ISO 13485 |
| Export markets | Europe, USA |
| 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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