SODEL

Certificate 39301

Rev. 4Supplemented

Valid until: May 16, 2028

Certificate 39301 is a valid Quality management system issued to SODEL and registered in EUDAMED. Valid until May 16, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 39301
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0459393014

Validity

Issued: Apr 1, 2026
Valid from: Apr 1, 2026
Valid until: May 16, 2028

Manufacturer

Manufacturer
Manufacturer SRN: FR-MF-000000367
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: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

39301SupplementedDec 11, 2024 → May 16, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa22Class IIb4

26 scopes

DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

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