Precisis Gesellschaft mit beschränkter Haftung

Certificate 2245875CE01

Rev. 5Supplemented

Valid until: Sep 1, 2027

Certificate 2245875CE01 is a valid Quality management system issued to Precisis Gesellschaft mit beschränkter Haftung and registered in EUDAMED. Valid until September 1, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 2245875CE01
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03442245875CE015

Validity

Issued: Mar 11, 2024
Valid from: Mar 11, 2024
Valid until: Sep 1, 2027

Notified body

Notified body: DEKRA Certification B.V.
Notified body SRN: 0344
Notified body country: Netherlands

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

2245875CE01AmendedSep 5, 2023 → Sep 1, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III1

1 scope

DEVICE
Class III

Documents

LanguagesEN