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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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Hangzhou SHINING3D Dental Technology Co., Ltd. 

Certificate IT351308

Rev. 1Issued
Valid until
Apr 23, 2031

Certificate IT351308 is a valid Quality management system issued to Hangzhou SHINING3D Dental Technology Co., Ltd.  and registered in EUDAMED. Valid until April 23, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number
IT351308
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1370IT3513081

Validity

Issued
Apr 24, 2026
Valid from
Apr 24, 2026
Valid until
Apr 23, 2031

Notified body

Notified body
BUREAU VERITAS ITALIA S.P.A.
Notified body SRN
1370
Notified body country
Italy

Characteristics

Sterile
No
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

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

  • Pre-formed Resins and Dental Crowns
    Class IIa
  • DEVICE
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Hangzhou SHINING3D Dental Technology Co., Ltd. 
Manufacturer SRN
CN-MF-000033456
Manufacturer country
China

Covered devices

  • Temporary CB ResinClass IIa
    697533870CB11JA