Ortho-Space Ltd

Certificate 3903006TD01

Rev. 0Issued

Valid until: Feb 1, 2028

Certificate 3903006TD01 is a valid Technical documentation 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: 3903006TD01
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03443903006TD010

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

Linked SSCPs

SSCP QAD-OR-1009

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III3

3 scopes

InSpace™ system
Class III
7290013396010WW
InSpace™ system
Class III
7290013396027XF
InSpace™ system
Class III
7290013396034XC

Documents

LanguagesEN