GME German Medical Engineering GmbH

Certificate HZ 1532570-1

Rev. Rev. 1Amended

Valid until: Oct 22, 2030

Certificate HZ 1532570-1 is a valid Quality management system issued to GME German Medical Engineering GmbH and registered in EUDAMED. Valid until October 22, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1532570-1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 1532570-1Rev. 1

Validity

Issued: Oct 24, 2025
Valid from: Oct 24, 2025
Valid until: Oct 22, 2030

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

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: No
QMS/MOS type: Class IIb only

History

Status changes

Amended

Supersedes

HZ 1532570-1Quality management systemIssuedOct 23, 2025 → Oct 22, 2030

Scope coverage

Class IIb1

1 scope

Z120402 - GENERAL MEDICINE INSTRUMENTS GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS
Class IIb

Documents

LanguagesEN