MicroPort Orthopedics Inc.

Certificate 022-00-00-MDR

Rev. 00Issued

Valid until: Jul 3, 2028

Certificate 022-00-00-MDR is a valid Quality management system issued to MicroPort Orthopedics Inc. and registered in EUDAMED. Valid until July 3, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 022-00-00-MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0426022-00-00-MDR00

Validity

Issued: Jul 4, 2023
Valid from: Jul 4, 2023
Valid until: Jul 3, 2028

Manufacturer

Manufacturer: MicroPort Orthopedics Inc.
Manufacturer SRN: US-MF-000010240
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0426
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Linked SSCPs

SSCP ENG02457

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2Class III2

3 scopes

Non-active osteo- and orthopaedic implants
Class IIbClass III
Profemur® Gladiator® Stems
Class III
PROFEMUR GLADIATOR Distal Centralizers
Class IIb

Documents

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