Active Medical Xcellence GmbH

Certificate 111178U2

Rev. 0Supplemented

Valid until: Dec 15, 2030

Certificate 111178U2 is a valid Quality management system issued to Active Medical Xcellence GmbH and registered in EUDAMED. Valid until December 15, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 111178U2
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0494111178U20

Validity

Issued: May 7, 2026
Valid from: May 7, 2026
Valid until: Dec 15, 2030

Notified body

Notified body: SLG PRÜF UND ZERTIFIZIERUNGS GMBH
Notified body SRN: 0494
Notified body country: Germany

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: Yes
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

111178U2Quality management systemAmendedMay 7, 2026 → Dec 15, 2030

Scope coverage

Class IIa2

2 scopes

Morcellator
Class IIa
DEVICE
Class IIa