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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

GRUPPO FARMAIMPRESA SRL

Certificate 021-00-05-MDR

Supplemented

Valid until: Jun 21, 2028

Overview

Certificate number: 021-00-05-MDR
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 6
Certificate ID: 0426021-00-05-MDR

Validity

Issued: May 19, 2026
Valid from: May 19, 2026
Valid until: Jun 21, 2028

Manufacturer

Manufacturer: GRUPPO FARMAIMPRESA SRL
Manufacturer SRN: IT-MF-000012625
Manufacturer country: Italy

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

Covered devices

ARTOX 2% (1 siringa preriempita)Class III
805574884FTMDR74YE

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

021-00-04-MDRTechnical documentationSupplementedMar 27, 2026 → Jun 21, 2028

Scope coverage

Unspecified1

1 scope

ARTOX 2% (1 siringa preriempita)
805574884FTMDR74YE

Documents

LanguagesENIT