Henan Tuoren Medical Device Co., Ltd

Certificate 28620228213

Rev. 01Issued

Valid until: Nov 11, 2030

Certificate 28620228213 is a valid Quality management system issued to Henan Tuoren Medical Device Co., Ltd and registered in EUDAMED. Valid until November 11, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620228213
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862022821301

Validity

Issued: Dec 15, 2025
Valid from: Dec 15, 2025
Valid until: Nov 11, 2030

Notified body

Notified body: Intertek Medical Notified Body AB
Notified body SRN: 2862
Notified body country: Sweden

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: Yes
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III4

4 scopes

Epidural and spinal anesthesia devices
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III

Documents

LanguagesEN