Intrauma S.p.A.

Certificate 033/MDR

Rev. 5Issued

Valid until: Jul 3, 2027

Certificate 033/MDR is a valid Quality management system issued to Intrauma S.p.A. and registered in EUDAMED. Valid until July 3, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 033/MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051033/MDR5

Validity

Issued: Feb 5, 2026
Valid from: Feb 5, 2026
Valid until: Jul 3, 2027

Manufacturer

Manufacturer: Intrauma S.p.A.
Manufacturer SRN: IT-MF-000005991
Manufacturer country: Italy

Notified body

Notified body: IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
Notified body SRN: 0051
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: 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 IIb2Class IIa1

3 scopes

Frese per chirurgia mininvasiva del piede / Burrs for foot minimally invasive surgery
Class IIa
Chiodi endomidollari, viti e relativi accessori per le fratture di femore / Intramedullary nails, screws and related accessories for femoral fractures
Class IIb
Sistema di fissazione interna del tipo placca/viti e relativi accessori / Internal plate/screw fixation system and related accessories
Class IIb

Documents

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