DeepHealth, Inc.

Certificate SCAR-10.2.2.3

Amended

Valid until: Mar 21, 2031

Certificate SCAR-10.2.2.3 is a valid Quality management system issued to DeepHealth, Inc. and registered in EUDAMED. Valid until March 21, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: SCAR-10.2.2.3
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 3022SCAR-10.2.2.3

Validity

Issued: May 26, 2026
Valid from: May 26, 2026
Valid until: Mar 21, 2031

Manufacturer

Manufacturer: DeepHealth, Inc.
Manufacturer SRN: US-MF-000051664
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 3022
Notified body country: Netherlands

Covered devices

Brain HealthClass IIa
8600051440023T3

Characteristics

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

History

Status changes

Amended

Supersedes

SCAR-10.2.2.2IssuedApr 15, 2026 → Mar 21, 2031

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb4Class IIa3

7 scopes

MDA 0315 - Software Z119082 - Various Bioimaging and Radiotherapy Instruments - Software Accessories
Class IIb
MDA 0315 - Software
Class IIa
DEVICE
Class IIa
DeepHealth Prostate
Class IIb
DeepHealth AI Node
Class IIb
DeepHealth ProstateAI
Class IIb
Brain Age
Class IIa

Documents

LanguagesEN