Ortho-Space Ltd

Certificate 3903006CE01

Rev. Rev. 0Issued

Valid until: Feb 1, 2028

Certificate 3903006CE01 is a valid Quality management system issued to Ortho-Space Ltd and registered in EUDAMED. Valid until February 1, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 3903006CE01
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03443903006CE01Rev. 0

Validity

Issued: Jan 8, 2024
Valid from: Jan 8, 2024
Valid until: Feb 1, 2028

Manufacturer

Manufacturer: Ortho-Space Ltd
Manufacturer SRN: IL-MF-000018637
Manufacturer country: Israel

Notified body

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

Covered devices

Characteristics

Sterile: Yes
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

No status changes or preceding certificates are recorded.

Scope coverage

Class III3

3 scopes

DEVICE
Class III
DEVICE
Class III
DEVICE
Class III

Documents

LanguagesEN