IGEA S.p.A.

Certificate 107/MDR

Rev. 5Supplemented

Valid until: May 2, 2028

Certificate 107/MDR is a valid Quality management system issued to IGEA S.p.A. and registered in EUDAMED. Valid until May 2, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 107/MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051107/MDR5

Validity

Issued: Jun 30, 2026
Valid from: Jun 30, 2026
Valid until: May 2, 2028

Manufacturer

Manufacturer: IGEA S.p.A.
Manufacturer SRN: IT-MF-000011242
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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

History

Status changes

Supplemented

Supersedes

107/MDRSupplementedNov 27, 2024 → May 2, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa3Class IIb1

4 scopes

Generatore di campi elettromagnetici pulsati a bassa frequenza ad uso terapeutico / Low frequency pulsed electromagnetic field generator for therapeutic use
Class IIa
Dispositivi per elettroporazione / Electroporation devices
Class IIb
Accessori per elettroporazione / Accessories for electroporation
Class IIa
Generatore di campi elettrici ad accoppiamento capacitivo per uso terapeutico / Capacitively coupled electric fields generator for therapeutic use
Class IIa

Documents

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