Teoresi MedTech s.r.l.

Certificate 114/MDR

Rev. 2Issued

Valid until: Jun 15, 2028

Certificate 114/MDR is a valid Quality management system issued to Teoresi MedTech s.r.l. and registered in EUDAMED. Valid until June 15, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 114/MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051114/MDR2

Validity

Issued: Jun 17, 2024
Valid from: Jun 17, 2024
Valid until: Jun 15, 2028

Manufacturer

Manufacturer: Teoresi MedTech s.r.l.
Manufacturer SRN: IT-MF-000028044
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 IIb1

1 scope

Dispositivo per ultrafiltrazione ematica / Blood ultrafiltration device
Class IIb

Documents

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