Oxipit, UAB

Certificate HZ 1550682-1

Rev. 3Supplemented

Valid until: Feb 22, 2027

Certificate HZ 1550682-1 is a valid Quality management system issued to Oxipit, UAB and registered in EUDAMED. Valid until February 22, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1550682-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 1550682-13

Validity

Issued: Feb 4, 2026
Valid from: Feb 4, 2026
Valid until: Feb 22, 2027

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

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: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 1550682-1Quality management systemReissuedFeb 15, 2024 → Feb 22, 2027

Scope coverage

Class IIb1

1 scope

Z129082 - Various functionalities exploring and treatment instruments – software - Standalone computer assisted diagnostic medical device software for chest X-ray images analysis and reporting
Class IIb

Documents

LanguagesEN