ADVITOS GmbH

Certificate G10 064517 0011

Rev. Rev. 00Issued

Valid until: Feb 28, 2029

Certificate G10 064517 0011 is a valid Quality management system issued to ADVITOS GmbH and registered in EUDAMED. Valid until February 28, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 064517 0011
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 064517 0011Rev. 00

Validity

Issued: Feb 29, 2024
Valid from: Feb 29, 2024
Valid until: Feb 28, 2029

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
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: Yes
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: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb4

4 scopes

F040101 - DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
Class IIb
F040202 - DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID
Class IIb
F0499 - DIALYSIS CONCENTRATES - OTHER
Class IIb
Z120902 - HAEMODIALYSIS INSTRUMENTS
Class IIb

Documents

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