Ursatec GmbH

Certificate ECM23MDR002

Rev. 0Issued

Valid until: Aug 1, 2028

Certificate ECM23MDR002 is a valid Quality management system issued to Ursatec GmbH and registered in EUDAMED. Valid until August 1, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: ECM23MDR002
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1282ECM23MDR0020

Validity

Issued: Aug 2, 2023
Valid from: Aug 2, 2023
Valid until: Aug 1, 2028

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: No
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 I1

1 scope

DEVICE
Class I