Atlas Copco (Wuxi) Compressor Co., Ltd.

Certificate CN23/00005220

Rev. 4Amended

Valid until: Oct 4, 2028

Certificate CN23/00005220 is a valid Quality management system issued to Atlas Copco (Wuxi) Compressor Co., Ltd. and registered in EUDAMED. Valid until October 4, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: CN23/00005220
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 1639CN23/000052204

Validity

Issued: Jan 28, 2026
Valid from: Jan 28, 2026
Valid until: Oct 4, 2028

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

Characteristics

Sterile: No
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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Amended

Supersedes

CN23/00005220Quality management systemSupplementedMay 9, 2025 → Oct 4, 2028

Scope coverage

Class IIb4Class IIa3

7 scopes

MDA0316, MDS1009
Class IIa
MDA0316, MDS1009, EMDN:Z120309
Class IIb
MDA0316, MDS1004, MDS1009, EMDN:Z120309
Class IIb
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN