MEDICAL CONSULTING SRL

Certificate 004-00-02-MDR

Rev. 02Supplemented

Valid until: Oct 26, 2027

Certificate 004-00-02-MDR is a valid Quality management system issued to MEDICAL CONSULTING SRL and registered in EUDAMED. Valid until October 26, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 004-00-02-MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0426004-00-02-MDR02

Validity

Issued: Mar 8, 2023
Valid from: Mar 8, 2023
Valid until: Oct 26, 2027

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

004-00-01-MDRQuality management systemAmendedNov 14, 2022 → Oct 26, 2027

Scope coverage

Class IIb3Class IIa2

4 scopes

Medical gas supply systems and parts thereof
Class IIbClass IIa
Compressed gas distribution systems
Class IIb
Vacuum pipeline systems
Class IIb
Anaesthetic gases scavenging systems
Class IIa

Documents

LanguagesITEN