Medtronic Xomed Inc

Certificate G11 041921 0040

Rev. Rev. 03Supplemented

Valid until: Feb 6, 2028

Certificate G11 041921 0040 is a valid Quality management system issued to Medtronic Xomed Inc and registered in EUDAMED. Valid until February 6, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: G11 041921 0040
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G11 041921 0040Rev. 03

Validity

Issued: Jun 12, 2026
Valid from: Jun 12, 2026
Valid until: Feb 6, 2028

Manufacturer

Manufacturer: Medtronic Xomed Inc
Manufacturer SRN: US-MF-000023264
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

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

History

Status changes

Supplemented

Supersedes

G11 041921 0040SupplementedMay 13, 2026 → Feb 6, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I5

5 scopes

Q03 - ENT DEVICES
Class I
T03 - PROTECTIONS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE)
Class I
P02 - ENT PROSTHESES
Class I
Z12 - INSTRUMENTS FOR FUNCTIONAL EXPLORATIONS AND THERAPEUTIC INTERVENTIONS
Class I
M04 - SPECIAL DRESSINGS
Class I

Documents

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