SEFAM

Certificate 39439

Rev. 7Supplemented

Valid until: Oct 15, 2028

Certificate 39439 is a valid Quality management system issued to SEFAM and registered in EUDAMED. Valid until October 15, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 39439
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0459394397

Validity

Issued: Jun 15, 2026
Valid from: Jun 15, 2026
Valid until: Oct 15, 2028

Manufacturer

Manufacturer: SEFAM
Manufacturer SRN: FR-MF-000009061
Manufacturer country: France

Notified body

Notified body
Notified body SRN: 0459
Notified body country: France

Covered devices

No specific devices are listed for this certificate.

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

Status changes

Supplemented

Supersedes

39439SupplementedJan 9, 2026 → Oct 15, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa1

1 scope

Dispositifs médicaux et leurs accessoires pour traitement des troubles respiratoires. Medical devices and their accessories for treatment of respiratory disorders.
Class IIa

Documents

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