itémedical bv

Certificate 2265778CE01

Rev. 1Amended

Valid until: Jan 1, 2029

Certificate 2265778CE01 is a valid Quality management system issued to itémedical bv and registered in EUDAMED. Valid until January 1, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2265778CE01
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03442265778CE011

Validity

Issued: Jan 25, 2024
Valid from: Jan 25, 2024
Valid until: Jan 1, 2029

Manufacturer

Manufacturer: itémedical bv
Manufacturer SRN: NL-MF-000010918
Manufacturer country: Netherlands

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

MediScore MDDGClass IIb
8720726596MediScoreMDDG89

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

2265778CE01IssuedJan 9, 2024 → Jan 1, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb1

1 scope

DEVICE
Class IIb

Documents

LanguagesEN