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Certificate 2975-MED-2515501 — Nano-X AI Ltd.

MD Atlas
Documents

Nano-X AI Ltd.

Certificate 2975-MED-2515501

Rev. 01Amended

Valid until: Jun 3, 2030

Certificate 2975-MED-2515501 is a valid Quality management system issued to Nano-X AI Ltd. and registered in EUDAMED. Valid until June 3, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2975-MED-2515501
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 29752975-MED-251550101

Validity

Issued: Jan 15, 2026
Valid from: Jan 15, 2026
Valid until: Jun 3, 2030

Notified body

Notified body
Notified body SRN: 2975
Notified body country: Germany

Characteristics

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

History

Status changes

Amended

Supersedes

2975-MED-2515501Quality management systemIssuedJun 4, 2025 → Jun 3, 2030

Scope coverage

Class IIa2

2 scopes

HealthOST (AI-Powered Medical Imaging Software for Assessment of Vertebral Morphology and Bone Density)
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN

No

Conditions applicable

No

MOS outside EUDAMED

No

QMS/MOS type

Basic UDI-DI data only

SZUTEST Konformitätsbewertungsstelle GmbH

Manufacturer

Manufacturer: Nano-X AI Ltd.
Manufacturer SRN: IL-MF-000010234
Manufacturer country: Israel

Covered devices

HealthOSTClass IIa
7290018016HealthOST2L