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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Documents

GINEVRI srl

Certificate IT350907

Rev. 1Amended

Valid until: Mar 15, 2031

Overview

Certificate number: IT350907
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1370IT3509071

Validity

Issued: Mar 16, 2026
Valid from: Mar 16, 2026
Valid until: Mar 15, 2031

Manufacturer

Manufacturer: GINEVRI srl
Manufacturer SRN: IT-MF-000034527
Manufacturer country: Italy

Notified body

Notified body: BUREAU VERITAS ITALIA S.P.A.
Notified body SRN: 1370
Notified body country: Italy

Covered devices

80538473603SEClass IIb
80538473603SE

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: Basic UDI-DI data and Class IIb

History

Status changes

Amended

Supersedes

IT350907-1Quality management systemIssuedMar 16, 2026 → Mar 15, 2031

Scope coverage

Class IIb2

2 scopes

Incubatrici Neonatali Fisse
Class IIb
DEVICE
Class IIb

Documents

LanguagesITEN