UNION DENTAL S.A.

Certificate 2025 CR 0043

Rev. 2Supplemented

Valid until: Feb 9, 2030

Certificate 2025 CR 0043 is a valid Quality management system issued to UNION DENTAL S.A. and registered in EUDAMED. Valid until February 9, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025 CR 0043
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 03182025 CR 00432

Validity

Issued: Mar 9, 2026
Valid from: Mar 9, 2026
Valid until: Feb 9, 2030

Notified body

Notified body: CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS
Notified body SRN: 0318
Notified body country: Spain

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

2025 CR 0043Quality management systemIssuedMar 9, 2026 → Feb 9, 2030

Scope coverage

Class IIa5

5 scopes

MDN 1209: Productos dentales no activos y no implantables / Non-active non-implantable dental
Class IIa
Dientes Artificiales / Artificial teeth
Class IIa
Bloque de polímero para férulas / Polymer blank for splints
Class IIa
Bloque de polímero para bases de dentaduras / Polymer blank for denture bases
Class IIa
Bloque de polímero para piezas dentales / Polymer blank for denture teeth
Class IIa

Documents

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