ACTIMI GmbH

Certificate MDR-0028

Rev. 2Supplemented

Valid until: Mar 10, 2030

Certificate MDR-0028 is a valid Quality management system issued to ACTIMI GmbH and registered in EUDAMED. Valid until March 10, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR-0028
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1304MDR-00282

Validity

Issued: Feb 26, 2026
Valid from: Feb 26, 2026
Valid until: Mar 10, 2030

Manufacturer

Manufacturer: ACTIMI GmbH
Manufacturer SRN: DE-MF-000024271
Manufacturer country: Germany

Notified body

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Notified body SRN: 1304
Notified body country: Slovenia

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: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

MDR-0028Quality management systemIssuedMar 11, 2025 → Mar 10, 2030

Scope coverage

Class IIa2

2 scopes

Vital signs telemetry instruments - medical device software
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN