Changzhou Endoclean Medical Device Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000017444 FEI 3021349683
- Devices
- 15
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Changzhou Endoclean Medical Device Co., Ltd. makes
The company manufactures single-use components for endoscopic procedures, including disposable endoscope valves systems and connecting tubes for endoscopic use, as well as CO₂ source tubing for endoscopy.
These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Search and filter all 15 devicesCompany details
- EUDAMED SRN
- CN-MF-000017444
- FDA FEI number
- 3021349683
- DUNS number
- 705006876
- EUDAMED status
- Active
- EUDAMED registered name
- Changzhou Endoclean Medical Device Co.,Ltd.
- Registered address
- NO.9, West Side of 4th Floor, Buliding E2 West Taihu Medical Industry, Incubator Park, NO.9 Changyang Road, Wujin District, 213000, Changzhou City, Jiangsu Province, China
- [email protected]
- PRRC contact
- Qi Wang
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 8 Mar 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- G26 104206 0006 Active
Quality assurance EU MDR
- Issued
- 9 Mar 2026
- Expires
- 8 Mar 2031
Frequently asked questions
How many devices does Changzhou Endoclean Medical Device Co., Ltd. have in the registry?
The registry currently lists 15 devices for Changzhou Endoclean Medical Device Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Changzhou Endoclean Medical Device Co., Ltd.'s devices?
Among its 15 most recently registered devices, Changzhou Endoclean Medical Device Co., Ltd. has devices listed in EUDAMED (5 devices), FDA 510(k) (3 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Changzhou Endoclean Medical Device Co., Ltd.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Changzhou Endoclean Medical Device Co., Ltd.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Changzhou Endoclean Medical Device Co., Ltd.?
EUDAMED lists 1 certificate for Changzhou Endoclean Medical Device Co., Ltd. (quality assurance) under MDR. 1 is recorded with the status issued. The most recent was issued on 9 Mar 2026.
What are the newest devices from Changzhou Endoclean Medical Device Co., Ltd. in the registry?
The most recently registered devices listed for Changzhou Endoclean Medical Device Co., Ltd. include VTL/WJC-241, Sterile Tray Liner, Endoclean EDKN-004006/004007/004008 and Endoclean EDKN-004002/004006/004007/004008.