Vertex-Dental B.V.

Certificate BE24/00000143

Rev. 2Supplemented

Valid until: Jun 3, 2029

Certificate BE24/00000143 is a valid Quality management system issued to Vertex-Dental B.V. and registered in EUDAMED. Valid until June 3, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: BE24/00000143
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639BE24/000001432

Validity

Issued: Mar 10, 2026
Valid from: Mar 10, 2026
Valid until: Jun 3, 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: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

BE24/00000143Quality management systemIssuedJun 3, 2024 → Jun 3, 2029

Scope coverage

Class IIa10

10 scopes

MDN1209
Class IIa
MDN1103
Class IIa
Heat-cured resin intended for the manufacturing of denture bases to form full or partial removable dentures
Class IIa
Self-cured resin intended for the manufacturing, repairing or expanding of denture bases to form full or partial removable dentures
Class IIa
Self-cured resin intended for the manufacturing, repairing or expanding of orthodontic base to form removable orthodontic appliances
Class IIa
Thermoplastic resin intended for the manufacturing of denture bases to form removable dentures
Class IIa
Photo-cured resin intended for 3D printing of removable occlusal splint or orthodontic retainers
Class IIa
Photo-cured resin for 3D printing of denture base to form full or partial removable dentures
Class IIa
Photo-cured resin intended for 3D printing of orthodontic activator (aligner)
Class IIa
Photo-cured resin intended for the manufacturing of 3D printed crowns, bridges, and artificial teeth
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIa10

10 scopes

MDN1209
Class IIa
MDN1103
Class IIa
Heat-cured resin intended for the manufacturing of denture bases to form full or partial removable dentures
Class IIa
Self-cured resin intended for the manufacturing, repairing or expanding of denture bases to form full or partial removable dentures
Class IIa
Self-cured resin intended for the manufacturing, repairing or expanding of orthodontic base to form removable orthodontic appliances
Class IIa
Thermoplastic resin intended for the manufacturing of denture bases to form removable dentures
Class IIa
Photo-cured resin intended for 3D printing of removable occlusal splint or orthodontic retainers
Class IIa
Photo-cured resin for 3D printing of denture base to form full or partial removable dentures
Class IIa
Photo-cured resin intended for 3D printing of orthodontic activator (aligner)
Class IIa
Photo-cured resin intended for the manufacturing of 3D printed crowns, bridges, and artificial teeth
Class IIa

Certificate BE24/00000143

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate BE24/00000143

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer