FAMADENT, S.L.U.

Certificate ES26/000001625

Rev. 1Issued

Valid until: Feb 16, 2031

Certificate ES26/000001625 is a valid Quality management system issued to FAMADENT, S.L.U. and registered in EUDAMED. Valid until February 16, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: ES26/000001625
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639ES26/0000016251

Validity

Issued: Feb 16, 2026
Valid from: Feb 16, 2026
Valid until: Feb 16, 2031

Manufacturer

Manufacturer: FAMADENT, S.L.U.
Manufacturer SRN: ES-MF-000000270
Manufacturer country: Spain

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: 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: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

MDN1209
Class IIa
Methyl-methacrylate polymers for the manufacture of dental prosthesis (denture bases and orthodontic plates)
Class IIa

Documents

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