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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

Artsana S.p.A.

Certificate CSQ001423

Rev. 00Issued

Valid until: Nov 1, 2028

Overview

Certificate number: CSQ001423
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0373CSQ00142300

Validity

Issued: Nov 2, 2023
Valid from: Nov 2, 2023
Valid until: Nov 1, 2028

Manufacturer

Manufacturer: Artsana S.p.A.
Manufacturer SRN: IT-MF-000010731
Manufacturer country: Italy

Notified body

Notified body: ISTITUTO SUPERIORE DI SANITA'
Notified body SRN: 0373
Notified body country: Italy

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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb4

4 scopes

CONTROL LUBGEL INFINITY2
Class IIb
CONTROL LUBGEL
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesENIT

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