Shenzhen Dongdixin Technology Co., Ltd.

Certificate FI23/0000008

Rev. Issue 4Supplemented

Valid until: Mar 20, 2026

Certificate FI23/0000008, a Quality management system issued to Shenzhen Dongdixin Technology Co., Ltd., has expired. View the full certificate record on MD Atlas.

Overview

Certificate number: FI23/0000008
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 6
Certificate ID: 0598FI23/0000008Issue 4

Validity

Issued: Dec 19, 2025
Valid from: Dec 20, 2025
Valid until: Mar 20, 2026

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

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 only

History

Status changes

Supplemented

Supersedes

FI23/0000008Quality management systemReinstatedApr 25, 2025 → Mar 20, 2026

Scope coverage

Class IIa4

4 scopes

MDA 0305, MDS 1009, MDT2010, MDT2011 EMDN V9099 Various devices not included in other classes - other 
Class IIa
MDA 0304, MDS 1009, MDT2010, MDT2011 EMDN Z12139001 Shock Wave Therapy Equipment
Class IIa
DEVICE
Class IIa
Shockwave Therapy Device: SW3200 Basic UDI-DI: 69264087SW001SL
Class IIa

Documents

LanguagesEN