Mathys AG Bettlach

Certificate G12 052905 0160

Rev. Rev. 08Issued

Valid until: Oct 23, 2027

Certificate G12 052905 0160 is a valid Quality management system issued to Mathys AG Bettlach and registered in EUDAMED. Valid until October 23, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: G12 052905 0160
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G12 052905 0160Rev. 08

Validity

Issued: Jan 13, 2025
Valid from: Jan 13, 2025
Valid until: Oct 23, 2027

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 III10Class IIb2

12 scopes

P090803 - HIP PROSTHESES ACETABULAR COMPONENTS
Class III
P090904 - UNICOMPARTMENTAL KNEE PROSTHESES (UNICONDYLAR
Class III
P9099 - IMPLANTABLE PROSTHETIC DEVICES - OTHER
Class IIb
P090804 - HIP PROSTHESES FEMORAL COMPONENTS
Class IIb
P090903 - BICOMPARTMENTAL PRIMARY IMPLANT KNEE PROSTHESES
Class III
P090907 - PATELLO-FEMORAL KNEE PROSTHESES
Class III
P090980 - KNEE PROSTHESES - ACCESSORIES
Class III
P090103 - GLENOID COMPONENTS
Class III
P090104 - SHOULDER PROSTHESES HUMERAL COMPONENTS
Class III
P090180 - SHOULDER PROSTHESES - ACCESSORIES
Class III
P090905 - REVISION KNEE PROSTHESES
Class III
P090880 - HIP PROSTHESES - ACCESSORIES
Class III

Documents

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