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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

MX Healthcare GmbH

Certificate SCAR-17.2.1.1

Amended

Valid until: Feb 23, 2027

Overview

Certificate number: SCAR-17.2.1.1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 3022SCAR-17.2.1.1

Validity

Issued: May 26, 2026
Valid from: May 26, 2026
Valid until: Feb 23, 2027

Manufacturer

Manufacturer: MX Healthcare GmbH
Manufacturer SRN: DE-MF-000006986
Manufacturer country: Germany

Notified body

Notified body: Scarlet NB B.V.
Notified body SRN: 3022
Notified body country: Netherlands

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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Amended

Supersedes

SCAR-17.2.1.0IssuedMar 31, 2026 → Feb 23, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb3

3 scopes

MDA 0315 - Software Z110302 - Mammography systems
Class IIb
DEVICE
Class IIb
Vara MG
Class IIb

Documents

LanguagesEN

Covered devices

Vara AIClass IIb
426073218VaraAIUJ