Data / Medical devices / China / Changzhou Endoclean Medical Device Co., Ltd.
Changzhou Endoclean Medical Device Co., Ltd.: FDA-registered device maker in Changzhou Jiangsu, China, 3 510(k) clearances
Changzhou Endoclean Medical Device Co., Ltd. is registered with the FDA (registration 3021349683) in Changzhou Jiangsu, China. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 29, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021349683
- Address
- West Side of 4th Floor, Building E2 West Taihu Medical Industry Incubator Park No. 9 Changyang Road Wujin District, Changzhou Jiangsu, China, 213000
- Owner or operator
- Changzhou Endoclean Medical Device Co., Ltd. (10083616)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 6, 2021
- Registered through
- 2027
- Brand names listed
- Adaptor, bulbs, miscellaneous, for endoscope, Bowl, Cleaning Sponge, Disposable Endoscope Valves System, Distal Tip Protector, Endoscope And Accessories, Endoscope Channel Accessory, Endoscope channel accessory and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Manufacturer | accessdata.fda.gov |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Manufacturer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope Introducer Kit | NWU | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Manufacturer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Manufacturer | accessdata.fda.gov |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | 2 | Manufacturer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trap, Sterile Specimen | BYZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2023 | K232244 | Disposable Endoscope Valves System | ODC | Substantially Equivalent | Changzhou Endoclean Medical Device Co., Ltd. | accessdata.fda.gov |
| October 7, 2022 | K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | OCX | Substantially Equivalent | Changzhou Endoclean Medical Device Co., Ltd. | accessdata.fda.gov |
| September 8, 2022 | K221331 | Disposable Endoscope Valves System | ODC | Substantially Equivalent | Changzhou Endoclean Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Bulbs, Miscellaneous, For Endoscope
- All makers of Endoscope Channel Accessory
- All makers of Endoscope Introducer Kit
- All makers of Lubricant, Patient
- All makers of Bedding, Disposable, Medical
- All makers of Cleaner, Ultrasonic, Medical Instrument
Updated November 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.