General Medical Italia LTD Swiss Branch

Certificate FI24/0000001

Rev. Issue 2Amended

Valid until: Jan 9, 2029

Certificate FI24/0000001 is a valid Quality management system issued to General Medical Italia LTD Swiss Branch and registered in EUDAMED. Valid until January 9, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: FI24/0000001
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0598FI24/0000001Issue 2

Validity

Issued: Dec 2, 2025
Valid from: Dec 3, 2025
Valid until: Jan 9, 2029

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

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: Class IIb only

History

Status changes

Amended
Amended

Supersedes

FI24/0000001Quality management systemIssuedJan 10, 2024 → Jan 9, 2029

Scope coverage

Class IIb4

4 scopes

EMDN Z11031101 Multifunctional Systems for Direct Digital Radiology
Class IIb
Model: Lucerna RF-TILT
Class IIb
Model: Lucerna U-ARM
Class IIb
Model: Genève 40 M
Class IIb

Documents

LanguagesEN