SOGEVA Srl

Certificate IT333749

Rev. 1Issued

Valid until: Jul 8, 2029

Certificate IT333749 is a valid Quality assurance issued to SOGEVA Srl and registered in EUDAMED. Valid until July 8, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: IT333749
Certificate type: Quality assurance
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1370IT3337491

Validity

Issued: Jul 9, 2024
Valid from: Jul 9, 2024
Valid until: Jul 8, 2029

Manufacturer

Manufacturer: SOGEVA Srl
Manufacturer SRN: IT-MF-000026322
Manufacturer country: Italy

Notified body

Notified body: BUREAU VERITAS ITALIA S.P.A.
Notified body SRN: 1370
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa3

3 scopes

MDA 0303 - Dispositivi attivi non impiantabili che utilizzano ipertermia/ipotermia
Class IIa
SOGEVA8X14 P, SOGEVA14X24 P, SOGEVA P (brand: Ghiaccio istantaneo in plastica)
Class IIa
SOGEVA8X14 TNT, SOGEVA14x24 TNT, SOGEVA TNT, PD003071 (brand: Ghiaccio istantaneo in tessuto non tessuto)
Class IIa

Documents

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