iSchemaView, Inc.

Certificate ECM25MDR011

Rev. 1Supplemented

Valid until: Jun 5, 2030

Certificate ECM25MDR011 is a valid Quality management system issued to iSchemaView, Inc. and registered in EUDAMED. Valid until June 5, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: ECM25MDR011
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1282ECM25MDR0111

Validity

Issued: Feb 10, 2026
Valid from: Feb 10, 2026
Valid until: Jun 5, 2030

Manufacturer

Manufacturer: iSchemaView, Inc.
Manufacturer SRN: US-MF-000040716
Manufacturer country: United States

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: Yes
SPP applicable

History

Status changes

Supplemented

Supersedes

ECM25MDR011Quality management systemIssuedJun 6, 2025 → Jun 5, 2030

Scope coverage

Class IIb2

2 scopes

Advanced Imaging Toolkit
Class IIb
Lumina 3D
Class IIb

Documents

LanguagesENIT