Changzhou Sifary Medical Technology Co., Ltd.

Certificate 1000316811

Rev. 02Supplemented

Valid until: Aug 14, 2029

Certificate 1000316811 is a valid Quality management system issued to Changzhou Sifary Medical Technology Co., Ltd. and registered in EUDAMED. Valid until August 14, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000316811
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0297100031681102

Validity

Issued: Jun 9, 2026
Valid from: Jun 9, 2026
Valid until: Aug 14, 2029

Notified body

Notified body: DQS Medizinprodukte GmbH
Notified body SRN: 0297
Notified body country: Germany

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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

1000239458AmendedAug 7, 2025 → Aug 14, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa7

7 scopes

MDA 0311 - Active non-implantable dental devices
Class IIa
MDA 0317/B - Active non-implantable devices for sterilisation
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN