Jiangsu Changmei Medtech Co., Ltd.

Certificate G10 088875 0012

Rev. Rev. 01Supplemented

Valid until: Mar 20, 2029

Certificate G10 088875 0012 is a valid Quality management system issued to Jiangsu Changmei Medtech Co., Ltd. and registered in EUDAMED. Valid until March 20, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 088875 0012
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 088875 0012Rev. 01

Validity

Issued: Jun 18, 2026
Valid from: Jun 18, 2026
Valid until: Mar 20, 2029

Manufacturer

Manufacturer: Jiangsu Changmei Medtech Co., Ltd.
Manufacturer SRN: CN-MF-000012609
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: 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

Status changes

Supplemented

Supersedes

G10 088875 0012IssuedMar 21, 2024 → Mar 20, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa8

8 scopes

G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS
Class IIa
G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE
Class IIa
G0399 - DIGESTIVE ENDOSCOPY DEVICES - OTHER
Class IIa
G030803 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES
Class IIa
R070203 - BRONCOPULMONARY ENDOSCOPY BRUSHES, SINGLE-USE
Class IIa
G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES
Class IIa
G030102 - DIGESTIVE ENDOSCOPY, PROGRESSIVE DILATORS
Class IIa
P099002 - ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
Class IIa

Documents

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