Ningbo Hitcm Medical Devices Co., Ltd.

Certificate HZ 1674737-1

Rev. Rev.0Issued

Valid until: Jan 15, 2031

Certificate HZ 1674737-1 is a valid Quality management system issued to Ningbo Hitcm Medical Devices Co., Ltd. and registered in EUDAMED. Valid until January 15, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1674737-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1674737-1Rev.0

Validity

Issued: Jan 16, 2026
Valid from: Jan 16, 2026
Valid until: Jan 15, 2031

Manufacturer

Manufacturer: Ningbo Hitcm Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000018667
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

K010101 - TROCAR, SINGLE-USE -Disposable Trocars with Lens Irrigation Channel
Class IIa

Documents

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