BRM Extremities S.r.l.

Certificate 060-00-00-MDR

Rev. 00Withdrawn

Valid until: Sep 19, 2029

Certificate 060-00-00-MDR, a Quality management system issued to BRM Extremities S.r.l., has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: 060-00-00-MDR
Certificate type: Quality management system
Certificate status: Withdrawn
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0426060-00-00-MDR00

Validity

Issued: Sep 20, 2024
Valid from: Sep 20, 2024
Valid until: Sep 19, 2029

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Withdrawn

Supersedes

060-00-00-MDRQuality management systemIssuedSep 20, 2024 → Sep 19, 2029

Scope coverage

Class I5Class IIa5

10 scopes

Non-active non-implantable instruments
Class I
Non-active non-implantable instruments
Class IIa
Accessories for the implantation of osteosynthesis screws
Class I
Accessories for the implant of device SILKTOE
Class I
Accessories for the implant of BIOPLAN device
Class I
Accessories for the implant of DIGITALIS device
Class I
Accessories for the implantation of osteosynthesis screws
Class IIa
Accessories for the implant of device SILKTOE
Class IIa
Accessories for the implant of device BIOPLAN
Class IIa
Accessories for the implant of device DIGITALIS
Class IIa