DH Healthcare GmbH

Certificate 28620120401

Rev. 01Issued

Valid until: Mar 13, 2027

Certificate 28620120401 is a valid Quality management system issued to DH Healthcare GmbH and registered in EUDAMED. Valid until March 13, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620120401
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862012040101

Validity

Issued: Jul 14, 2022
Valid from: Jul 14, 2022
Valid until: Mar 13, 2027

Notified body

Notified body: Intertek Medical Notified Body AB
Notified body SRN: 2862
Notified body country: Sweden

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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa15

15 scopes

Software for Imaging and Clinical Information
Class IIa
ORBIS Medication
Class IIa
clinalytix
Class IIa
clinalytix Rules
Class IIa
DeepUnity Viewer
Class IIa
ORBIS ICU-Manager
Class IIa
ORBIS Anesthesia
Class IIa
DeepUnity Diagnost
Class IIa
ORBIS Clinical Support
Class IIa
DeepUnity Viewer
Class IIa
clinalytix Medical AI
Class IIa
DxCare Prescriptions Multimodales
Class IIa
amPHI
Class IIa
PACSonWEB Enterprise
Class IIa
DeepUnity PACSonWEB
Class IIa

Documents

LanguagesEN