Biotechmed S.r.l.

Certificate IT326369

Rev. 1Issued

Valid until: Oct 17, 2028

Certificate IT326369 is a valid Quality management system issued to Biotechmed S.r.l. and registered in EUDAMED. Valid until October 17, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: IT326369
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1370IT3263691

Validity

Issued: Oct 18, 2023
Valid from: Oct 18, 2023
Valid until: Oct 17, 2028

Manufacturer

Manufacturer: Biotechmed S.r.l.
Manufacturer SRN: IT-MF-000030231
Manufacturer country: Italy

Notified body

Notified body: BUREAU VERITAS ITALIA S.P.A.
Notified body SRN: 1370
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: No
Intended medical purpose: No
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 IIa2

2 scopes

MDA 0315 - Software - Strumentazione varia per supporto e monitoraggio dei parametri vitali - Dispositivi medici software
Class IIa
THOLOMEUS (versione 2.4.1)
Class IIa

Documents

LanguagesIT