Shandong Huge Dental Material Corporation

Certificate CN24/00001821

Rev. 5Supplemented

Valid until: Mar 26, 2029

Certificate CN24/00001821 is a valid Quality management system issued to Shandong Huge Dental Material Corporation and registered in EUDAMED. Valid until March 26, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: CN24/00001821
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 5
Certificate ID: 1639CN24/000018215

Validity

Issued: Apr 28, 2025
Valid from: Apr 28, 2025
Valid until: Mar 26, 2029

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

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: —
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

CN24/00001821Quality management systemAmendedJan 9, 2025 → Mar 26, 2029

Scope coverage

Class IIa16

16 scopes

MDN1209
Class IIa
MDN1103
Class IIa
PMMA Block
Class IIa
Synthetic polymer teeth
Class IIa
Invisible Orthodontic Appliance
Class IIa
Glass Ionomer Cement
Class IIa
Zirconia Block
Class IIa
Dual Cure Resine Cement
Class IIa
Light Cure Dental Adhesive
Class IIa
Light Cure Veneer Cement
Class IIa
Universal Composite restorative
Class IIa
Enamel Coating Resin
Class IIa
Flowable Composite Restorative
Class IIa
Resin Modified Class Ionomer Cement
Class IIa
Phosphoric Acid Etching Gel
Class IIa
Ceramic Coupling Agent
Class IIa

Documents

LanguagesEN