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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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MD Atlas
Documents

MEDES S.r.l.

Certificate 042-00-02-MDR

Rev. 02Supplemented

Valid until: Feb 19, 2029

Overview

Certificate number: 042-00-02-MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0426042-00-02-MDR02

Validity

Issued: Jan 16, 2026
Valid from: Jan 16, 2026
Valid until: Feb 19, 2029

Manufacturer

Manufacturer: MEDES S.r.l.
Manufacturer SRN: IT-MF-000025275
Manufacturer country: Italy

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: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

042-00-01-MDRQuality management systemSupplementedOct 22, 2025 → Feb 19, 2029

Scope coverage

Class IIb2Class IIa2

4 scopes

MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES
Class IIb
MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES
Class IIa
Compressed gas distribution systems and endocavitary aspiration systems
Class IIb
Anaesthetic gas scavenging system and/or nitric oxide mixture
Class IIa

Documents

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