WOLF-Medizintechnik GmbH

Certificate 2023-MDR/QS-024

Rev. 00Issued

Valid until: Aug 21, 2028

Certificate 2023-MDR/QS-024 is a valid Quality management system issued to WOLF-Medizintechnik GmbH and registered in EUDAMED. Valid until August 21, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023-MDR/QS-024
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652023-MDR/QS-02400

Validity

Issued: Aug 21, 2023
Valid from: Aug 21, 2023
Valid until: Aug 21, 2028

Manufacturer

Manufacturer: WOLF-Medizintechnik GmbH
Manufacturer SRN: DE-MF-000005165
Manufacturer country: Germany

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Brachytherapy radiation System
Class IIb
x-ray therapy unit with accessories / Model Name WOmed ioRT-50
Class IIb

Documents

LanguagesEN