Inspire Medical Systems Inc

Certificate 3830882CE01

Rev. 0Issued

Valid until: Jul 17, 2029

Certificate 3830882CE01 is a valid Quality management system issued to Inspire Medical Systems Inc and registered in EUDAMED. Valid until July 17, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 3830882CE01
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03443830882CE010

Validity

Issued: Jul 17, 2024
Valid from: Jul 17, 2024
Valid until: Jul 17, 2029

Manufacturer

Manufacturer: Inspire Medical Systems Inc
Manufacturer SRN: US-MF-000013604
Manufacturer country: United States

Notified body

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

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: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III6

6 scopes

DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III

Documents

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