SOLTEC S.r.l.

Certificate 0425-MDR-030140-00

Rev. 00Issued

Valid until: Jul 30, 2030

Certificate 0425-MDR-030140-00 is a valid Quality management system issued to SOLTEC S.r.l. and registered in EUDAMED. Valid until July 30, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 0425-MDR-030140-00
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04250425-MDR-030140-0000

Validity

Issued: Jul 31, 2025
Valid from: Jul 31, 2025
Valid until: Jul 30, 2030

Manufacturer

Manufacturer: SOLTEC S.r.l.
Manufacturer SRN: IT-MF-000018179
Manufacturer country: Italy

Notified body

Notified body: ICIM S.P.A.
Notified body SRN: 0425
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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

DISPOSITIVI PER LAVAGGIO E DISINFEZIONE DI DISPOSITIVI MEDICI (DEVICES FOR WASHING AND DISINFECTION OF MEDICAL DEVICES)
Class IIb
DISPOSITIVI PER LAVAGGIO E DISINFEZIONE DI DISPOSITIVI MEDICI (DEVICES FOR WASHING AND DISINFECTION OF MEDICAL DEVICES)
Class IIb

Documents

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