MatOrtho Limited

Certificate 1434-MDR-010/2025

Rev. 1/25.06.2025/S/080/BM/2023Issued

Valid until: Jun 24, 2030

Certificate 1434-MDR-010/2025 is a valid Quality management system issued to MatOrtho Limited and registered in EUDAMED. Valid until June 24, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 1434-MDR-010/2025
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 14341434-MDR-010/20251/25.06.2025/S/080/BM/2023

Validity

Issued: Jun 25, 2025
Valid from: Jun 25, 2025
Valid until: Jun 24, 2030

Manufacturer

Manufacturer: MatOrtho Limited
Manufacturer SRN: GB-MF-000007614
Manufacturer country: United Kingdom

Notified body

Notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Notified body SRN: 1434
Notified body country: Poland

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: No
Mechanism of scrutiny: No
Intended medical purpose: Yes
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

P09080402 - HIP RESURFACING FEMORAL COMPONENTS
Class III
ReCerf™ Hip Resurfacing System: Ceramic Resurfacing Head
Class III

Documents

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