Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000021464

Devices: 160
Registrations: EUDAMED

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.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue160

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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: [email protected]
PRRC contact: Hong Zhou(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 10 Jun 2031

TÜV SÜD Product Service GmbH 0123 1 certificate

G15 065913 0018 Active Supplemented

Quality management system EU MDR

Issued
19 Jun 2026

Expires
10 Jun 2031

Reason
Add device or group

What Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. makes

Catalogue160

Disposable trocar Ref D10×150

Disposable trocar Ref DB-OPT-10-150

Disposable Linear Cutter Stapler and Staple Cartridge Ref XQA-100-4.5

Disposable trocar Ref D15×100

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ30LA

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ6035

Disposable trocar Ref D5A×100

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYH60M

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ6025

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ75MA

Disposable trocar Ref D3×100

Disposable trocar Ref DB-OPT-DT-12-100

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYH4548A

Disposable Circular Stapler Ref WGWC-26、

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ4545

Disposable trocar Ref DO10A×150

Disposable Circular Stapler for Hemorrhoid Ref GWC-34

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ45LA

Disposable Endoscopic Linear Cutter Stapler and Cartridge---stapler Ref XNY-M

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ60HA

Disposable trocar Ref D3A×100

Disposable trocar Ref DB-OPT-12-150

Disposable Circular Stapler Ref WGWB-29

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ7538A

Disposable trocar Ref DK5×100

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ60MA

Disposable trocar Ref DB-10-150

Disposable trocar Ref DBK-12-100

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYH6035A

Disposable trocar Ref DK10A×100

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYH3025A

Disposable Linear Cutter Stapler and Staple Cartridge Ref XQA-60-3.8

Disposable Endoscopic Linear Cutter Stapler and Cartridge---stapler Ref XMY-L

Disposable Circular Stapler Ref WGWC-22

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ6038

Disposable Circular Stapler Ref WGWB-24

Disposable trocar Ref D12A×150

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYH4525A

Disposable trocar Ref DO5×150

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYH6025A

Disposable Circular Stapler Ref WGWC-20

Disposable trocar Ref DB-OPT-5-150

Disposable trocar Ref DB-DT-5-100

Disposable Linear Cutter Stapler and Staple Cartridge Ref XQ-80-4.5

Disposable Circular Stapler Ref WGWC-29、

Disposable trocar Ref DB-DT-10-150

Disposable trocar Ref DO10×100

Disposable Linear Cutter Stapler and Staple Cartridge--Cartridge Ref A100-3.8

Disposable Circular Stapler Ref WGWA-32

Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge Ref XNYJ60LAC

Company details

EUDAMED certificates1

TÜV SÜD Product Service GmbH 0123 ·1 certificate

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Certifiers

TÜV SÜD Product Service GmbH 0123 1 certificate