OSARTIS GmbH

Certificate G15 107266 0028

Rev. Rev. 01Issued

Valid until: Apr 26, 2028

Certificate G15 107266 0028 is a valid Quality management system issued to OSARTIS GmbH and registered in EUDAMED. Valid until April 26, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: G15 107266 0028
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G15 107266 0028Rev. 01

Validity

Issued: Oct 16, 2025
Valid from: Oct 16, 2025
Valid until: Apr 26, 2028

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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 I1Class IIb1Class III1

3 scopes

P09 - ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS
Class I
MDN 1102 - Non-active osteo- and orthopaedic implants
Class IIb
MDN 1102 - Non-active osteo- and orthopaedic implants
Class III

Documents

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