Certificate G10 106872 0003

Certificate number

G10 106872 0003

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Version

1

Certificate ID

0123G10 106872 0003Rev. 01

Issued

May 23, 2023

Valid from

May 23, 2023

Valid until

Jul 18, 2026

Manufacturer

Oticon Medical AB

Manufacturer SRN

SE-MF-000000724

Manufacturer country

Sweden

Notified body

TÜV SÜD Product Service GmbH

Notified body SRN

0123

Notified body country

Germany

No specific devices are listed for this certificate.

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

No status changes or preceding certificates are recorded.