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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.

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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
PRRC contact
Hong Zhou(public in EUDAMED)

EUDAMED certificates1

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

EUDAMED certificates (1)

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