Changzhou Endoclean Medical Device Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 13 device types, 2 products catalogued, 3 clearances.
Changzhou Endoclean Medical Device Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Lubricant, Patient, Endoscopic Bite Block and 11 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021349683 |
| FEI number | 3021349683 |
| DUNS | 705006876 |
| Establishment type | Repacker / relabeller, Manufacturer |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | West Side of 4th Floor, Building E2 West Taihu Medical Industry |
| Postal code | 213000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | 2021 | 43 | |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | Class 1 | Adaptor, bulbs, miscellaneous, for endoscope, Distal Tip Protector | 2022 | 6 |
| Bedding, Disposable, Medical | Class 1 | Transport pad | 2023 | 308 |
| Bottle, Collection, Vacuum | Class 2 | Bowl | 2023 | 88 |
| Cleaner, Ultrasonic, Medical Instrument | Class 1 | Endoscopy Kit | 2023 | 48 |
| Endoscope Channel Accessory | Class 2 | Disposable Endoscope Valves System, Endoscope Channel Accessory | 2022 | 21 |
| Endoscope Introducer Kit | Class 2 | Endoscopy Kit | 2023 | 2 |
| Endoscopic Bite Block | Class 1 | 2021 | 44 | |
| Endoscopic Irrigation/Suction System | Class 2 | Endoscope And Accessories | 2022 | 10 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Cleaning Sponge | 2023 | 266 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | Class 2 | Endoscope And Accessories | 2022 | 5 |
| Lubricant, Patient | Class 1 | Lubricating Jelly | 2023 | 33 |
| Trap, Sterile Specimen | Class 2 | 2021 | 19 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232244 | 2023-11-29 | ODC | Traditional | This company |
| K221310 | 2022-10-07 | OCX | Traditional | This company |
| K221331 | 2022-09-08 | ODC | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2019 |
|---|---|
| Main products | Endoscope cleaning consumables, Irrigation tubes |
| Certifications | CE, FDA 510K, ISO 13485 |
| Export markets | US, UK, France, Germany, Australia |
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.
The manufacturer named here can complete this record.