Medoc Ltd

Certificate ECM25MDR003

Rev. 0Issued

Valid until: Feb 11, 2030

Certificate ECM25MDR003 is a valid Quality management system issued to Medoc Ltd and registered in EUDAMED. Valid until February 11, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: ECM25MDR003
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1282ECM25MDR0030

Validity

Issued: Feb 11, 2025
Valid from: Feb 11, 2025
Valid until: Feb 11, 2030

Manufacturer

Manufacturer: Medoc Ltd
Manufacturer SRN: IL-MF-000017313
Manufacturer country: Israel

Notified body

Notified body
Notified body SRN: 1282
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: Yes
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa14

14 scopes

AlgoMed FPIX System
Class IIa
TSA 2
Class IIa
TSA 2 AIR
Class IIa
Q-Sense
Class IIa
Thermode 30x30mm (TSA 2)
Class IIa
Thermode 16x16mm (TSA 2)
Class IIa
Thermode fMRI 30*30mm - including fMRI filter
Class IIa
Thermode fMRI 16X16mm - including fMRI filter
Class IIa
Thermode CHEPS
Class IIa
Thermode CHEPS fMRI
Class IIa
Thermode 6mm diameter
Class IIa
Thermode 30x30mm (Q-Sense)
Class IIa
Thermode 30x30mm (TSA 2 AIR)
Class IIa
Medoc Main Station Software
Class IIa

Documents

LanguagesITEN