UAB Inovatyvi Medicina

Certificate ECM26MDR004

Rev. 0Issued

Valid until: May 11, 2031

Certificate ECM26MDR004 is a valid Quality management system issued to UAB Inovatyvi Medicina and registered in EUDAMED. Valid until May 11, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: ECM26MDR004
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1282ECM26MDR0040

Validity

Issued: May 12, 2026
Valid from: May 12, 2026
Valid until: May 11, 2031

Notified body

Notified body: ENTE CERTIFICAZIONE MACCHINE SRL
Notified body SRN: 1282
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: Yes
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 IIb3Class I3

6 scopes

SENTANTE™ ENDOVASCULAR ROBOTIC SYSTEM
Class IIb
SENTACLES™ left-handed and right-handed orientation
Class IIb
Workstation cassettes
Class IIb
SENTACLES™ manual release kit
Class I
SENTANTE™ Bedside Unit drape
Class I
SENTANTE™ Introducer extension connection kit
Class I