Metaltronica SpA

Certificate 046/MDR

Rev. 5Supplemented

Valid until: Aug 1, 2027

Certificate 046/MDR is a valid Quality management system issued to Metaltronica SpA and registered in EUDAMED. Valid until August 1, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 046/MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051046/MDR5

Validity

Issued: Jun 9, 2026
Valid from: Jun 9, 2026
Valid until: Aug 1, 2027

Manufacturer

Manufacturer: Metaltronica SpA
Manufacturer SRN: IT-MF-000014684
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

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: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

046/MDRSupplementedMar 12, 2026 → Aug 1, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2

2 scopes

Mammografi convenzionali / Conventional mammography units
Class IIb
Mammografi digitali / Digital mammography units
Class IIb

Documents

LanguagesENIT