Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000021464
- Devices
- 160
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. makes
The company manufactures single-use surgical instruments, including gastric calibration tubes and disposable trocars (bladeless, optical, blunt-tip, spiral, and bladed varieties) for minimally invasive procedures.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) registry. The manufacturer operates from China.
Catalogue
Search and filter all 160 devicesShowing 1-50 of 160
Company details
- EUDAMED SRN
- CN-MF-000021464
- EUDAMED status
- Active
- EUDAMED registered name
- Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.
- Registered address
- No.51, Shuishan Road, Zhonglou Economic Development District, 213023, Changzhou, China
- [email protected]
- PRRC contact
- Hong Zhou
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 10 Jun 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 065913 0018 Active
Quality management system EU MDR
- Issued
- 19 Jun 2026
- Expires
- 10 Jun 2031
- Reason
- Add device or group
Frequently asked questions
How many devices does Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. have in the registry?
The registry currently lists 160 devices for Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.'s devices?
Among its 50 most recently registered devices, Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.?
EUDAMED lists 1 certificate for Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. (quality management system) under MDR. The most recent was issued on 19 Jun 2026.
What are the newest devices from Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. in the registry?
The most recently registered devices listed for Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. include Disposable Linear Cutter Stapler and Staple Cartridge--Cartridge, Disposable trocar, Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge and Disposable Circular Stapler.