Medtronic CoreValve LLC

Certificate 2266996CE03

Rev. 0Issued

Valid until: Jun 1, 2028

Certificate 2266996CE03 is a valid Quality management system issued to Medtronic CoreValve LLC and registered in EUDAMED. Valid until June 1, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2266996CE03
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03442266996CE030

Validity

Issued: Nov 13, 2023
Valid from: Nov 13, 2023
Valid until: Jun 1, 2028

Manufacturer

Manufacturer: Medtronic CoreValve LLC
Manufacturer SRN: US-MF-000019985
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

Confida™ Brecker GuidewireClass III
0763000B000226786

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III1

1 scope

DEVICE
Class III

Documents

LanguagesEN