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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

GEM SRL

Certificate CSQ0019240225

Rev. 02Supplemented

Valid until: May 15, 2029

Overview

Certificate number: CSQ0019240225
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0373CSQ001924022502

Validity

Issued: Mar 12, 2025
Valid from: Mar 12, 2025
Valid until: May 15, 2029

Manufacturer

Manufacturer: GEM SRL
Manufacturer SRN: IT-MF-000012892
Manufacturer country: Italy

Notified body

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

Covered devices

Surgical Glue Glubran 2Class III
803190219X

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
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 only

History

Status changes

Supplemented

Supersedes

CSQ0019240124Quality management systemSupplementedMay 21, 2024 → May 15, 2029

Scope coverage

Class III1

1 scope

DEVICE
Class III

Documents

LanguagesENIT