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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

EVOLUTIS

Certificate 074-00-00-MDR

Rev. 00Withdrawn

Valid until: Apr 21, 2030

Overview

Certificate number: 074-00-00-MDR
Certificate type: Quality management system
Certificate status: Withdrawn
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0426074-00-00-MDR00

Validity

Issued: Apr 22, 2025
Valid from: Apr 22, 2025
Valid until: Apr 21, 2030

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

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: No
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

Status changes

Withdrawn

Supersedes

074-00-00-MDRQuality management systemIssuedApr 22, 2025 → Apr 21, 2030

Scope coverage

Class IIa5Class I5

9 scopes

Non-active non-implantable instruments
Class IIaClass I
Femoral stem instruments
Class I
Femoral stem instruments
Class IIa
Femoral cups instruments
Class I
Femoral cups instruments
Class IIa
Total knee prosthesis and knee ligament repair instruments
Class I
Total knee prosthesis and knee ligament repair instruments
Class IIa
Shoulder instruments
Class I
Shoulder instruments
Class IIa

Documents

LanguagesENIT

Manufacturer

Manufacturer: EVOLUTIS
Manufacturer SRN: FR-MF-000000492
Manufacturer country: France