Jiangsu Power-endo Medical Technology Co., Ltd

Certificate CN25/00007115

Rev. 2Supplemented

Valid until: Oct 22, 2030

Certificate CN25/00007115 is a valid Quality management system issued to Jiangsu Power-endo Medical Technology Co., Ltd and registered in EUDAMED. Valid until October 22, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: CN25/00007115
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639CN25/000071152

Validity

Issued: Feb 16, 2026
Valid from: Feb 16, 2026
Valid until: Oct 22, 2030

Notified body

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

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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

CN25/00007115Quality management systemIssuedOct 22, 2025 → Oct 22, 2030

Scope coverage

Class IIa6Class I2

8 scopes

MDN1208, MDS1005
Class I
MDN1208, MDS1005
Class IIa
DEVICE
Class I
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
Sterile Disposable Dilation Balloon Catheters
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN