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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

France Développement Electronique

Certificate ECM25MDR010

Rev. 0Issued

Valid until: Apr 29, 2030

Overview

Certificate number: ECM25MDR010
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1282ECM25MDR0100

Validity

Issued: Apr 30, 2025
Valid from: Apr 30, 2025
Valid until: Apr 29, 2030

Manufacturer

Manufacturer: France Développement Electronique
Manufacturer SRN: FR-MF-000004028
Manufacturer country: France

Notified body

Notified body: ENTE CERTIFICAZIONE MACCHINE SRL
Notified body SRN: 1282
Notified body country: Italy

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: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

DEVICE
Class IIa

Documents

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