Changzhou Endoclean Medical Device Co., Ltd.
Changzhou Jiangsu, CN
CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD. appears in FDA device records in Changzhou Jiangsu, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Changzhou Endoclean Medical Device Co., Ltd. between 2022 and 2023. The busiest year on record is 2022, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232244 | Disposable Endoscope Valves System | ODC | Substantially Equivalent | |
| K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | OCX | Substantially Equivalent | |
| K221331 | Disposable Endoscope Valves System | ODC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3021349683 | 3021349683 | CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD. | West Side of 4th Floor, Building E2 West Taihu Medical Industry, Changzhou Jiangsu 213000 CN | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- KMEBedding, Disposable, Medical
- KDQBottle, Collection, Vacuum
- FLGCleaner, Ultrasonic, Medical Instrument
- ODCEndoscope Channel Accessory
- NWUEndoscope Introducer Kit
- MNKEndoscopic Bite Block
- OCXEndoscopic Irrigation/Suction System
- NABGauze / Sponge,Nonresorbable For External Use
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- KMJLubricant, Patient
- BYZTrap, Sterile Specimen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain