Telesair, Inc

Certificate 28620153855

Rev. 01Issued

Valid until: Jul 30, 2028

Certificate 28620153855 is a valid Quality management system issued to Telesair, Inc and registered in EUDAMED. Valid until July 30, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620153855
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862015385501

Validity

Issued: May 20, 2026
Valid from: May 20, 2026
Valid until: Jul 30, 2028

Manufacturer

Manufacturer: Telesair, Inc
Manufacturer SRN: US-MF-000037957
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2862
Notified body country: Sweden

Covered devices

Bonhawa Respiratory HumidifierClass IIa
08600093122A5X

Characteristics

Sterile: No
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: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Respiratory Humidifier and accessories
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN