Shenzhen Anke High-tech Co., Ltd.

Certificate G10 043041 0023

Rev. Rev. 00Issued

Valid until: Mar 26, 2029

Certificate G10 043041 0023 is a valid Quality management system issued to Shenzhen Anke High-tech Co., Ltd. and registered in EUDAMED. Valid until March 26, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 043041 0023
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 043041 0023Rev. 00

Validity

Issued: Mar 27, 2024
Valid from: Mar 27, 2024
Valid until: Mar 26, 2029

Manufacturer

Manufacturer: Shenzhen Anke High-tech Co., Ltd.
Manufacturer SRN: CN-MF-000016473
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
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: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1Class IIb1

2 scopes

Z11050102 - OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
Class IIa
Z11030603 - COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
Class IIb

Documents

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