IROMED GROUP S.R.L.

Certificate IT351643

Rev. 1Issued

Valid until: Apr 13, 2031

Certificate IT351643 is a valid Quality management system issued to IROMED GROUP S.R.L. and registered in EUDAMED. Valid until April 13, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: IT351643
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1370IT3516431

Validity

Issued: Apr 14, 2026
Valid from: Apr 14, 2026
Valid until: Apr 13, 2031

Manufacturer

Manufacturer: IROMED GROUP S.R.L.
Manufacturer SRN: IT-MF-000031267
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 1370
Notified body country: Italy

Covered devices

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: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2Class I1

3 scopes

GENERAL MEDICINE INSTRUMENTS – OTHER
Class IIa
DEVICE
Class IIa
DEVICE
Class I

Documents

LanguagesIT