Miconvey Technologies Co., Ltd.

Certificate HZ 2166637-1

Rev. 1Supplemented

Valid until: Sep 29, 2029

Certificate HZ 2166637-1 is a valid Quality management system issued to Miconvey Technologies Co., Ltd. and registered in EUDAMED. Valid until September 29, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2166637-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2166637-11

Validity

Issued: Jul 2, 2025
Valid from: Jul 2, 2025
Valid until: Sep 29, 2029

Manufacturer

Manufacturer: Miconvey Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000031532
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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

HZ 2166637-1Quality management systemIssuedSep 30, 2024 → Sep 29, 2029

Scope coverage

Class IIb1Class IIa1

2 scopes

K020201 - DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE USE ULTRASONIC SURGERY INSTRUMENTS, SINGLE-USE Z120108 - GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS INSTRUMENTS FOR ULTRASONIC SURGERY H020301 - STAPLERS FOR VIDEOSURGERY LINEAR STAPLERS FOR VIDEOSURGERY H020201 - STAPLERS, OPEN SURGERY LINEAR STAPLERS, OPEN SURGERY
Class IIb
H020301 - LINEAR STAPLERS FOR VIDEOSURGERY H020201 - LINEAR STAPLERS, OPEN SURGERY
Class IIa

Documents

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