Biomet Microfixation

Certificate MDR 726882

Rev. R002Supplemented

Valid until: May 13, 2031

Certificate MDR 726882 is a valid Quality management system issued to Biomet Microfixation and registered in EUDAMED. Valid until May 13, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 726882
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 726882R002

Validity

Issued: Jun 4, 2026
Valid from: Jun 4, 2026
Valid until: May 13, 2031

Notified body

Notified body: BSI Group The Netherlands B.V.
Notified body SRN: 2797
Notified body country: Netherlands

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

Status changes

Supplemented

Supersedes

MDR 726882AmendedApr 15, 2026 → May 13, 2031

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb4Class III2Class IIa2Class I2

10 scopes

Bone Fixation Screw
Class IIb
Bone Fixation Systems
Class IIb
Custom-made 'Temporomandibular reconstruction'
Class III
Motorised Orthopaedic Surgery Instruments, Sterile
Class IIa
Orthopaedic Instrumentation Non-Sterile
Class IIa
OtoMimix Bone Replacement System
Class III
Reusable instruments 'Orthopaedic Instruments'
Class I
RibFIX Advantage Implants
Class IIb
Sterile Instrument 'Orthopaedic Instruments'
Class I
SternaLock 360 Sternal Closure System Implants
Class IIb

Documents

LanguagesEN