Institut Straumann AG

Certificate G10 020326 0062

Rev. Rev. 07Reissued

Valid until: Jun 15, 2030

Certificate G10 020326 0062 is a valid Quality management system issued to Institut Straumann AG and registered in EUDAMED. Valid until June 15, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 020326 0062
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 020326 0062Rev. 07

Validity

Issued: Jun 4, 2025
Valid from: Jun 16, 2025
Valid until: Jun 15, 2030

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: Yes
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

Supersedes

G10 020326 0062SupplementedJun 7, 2024 → Jun 15, 2025

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa6Class IIb2

8 scopes

L159099 - ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
Class IIa
P010201 - DENTAL IMPLANTS AND ACCESSORIES
Class IIa
Q010205 - PRE-FORMED RESINS AND DENTAL CROWNS
Class IIa
Q010699 - MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
Class IIa
P010201 - DENTAL IMPLANTS AND ACCESSORIES
Class IIb
Z12011401 - SURGICAL NAVIGATION SYSTEM
Class IIa
Q010599 - DENTAL INSTRUMENTS, SINGLE-USE - OTHER
Class IIa
P01020101 - DENTAL IMPLANTS
Class IIb

Documents

LanguagesEN