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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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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

Manufacturer

Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.
Manufacturer SRN
CN-MF-000009429
Manufacturer country
China

Covered devices

  • Bite GoneClass IIa
    69264087CH001HT