Certificate 44911220476

Certificate number

44911220476

Certificate type

Quality management system

Certificate status

Supplemented

Applicable legislation

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

Version

2

Certificate ID

0044449112204762

Issued

Apr 22, 2024

Valid from

Apr 22, 2024

Valid until

Dec 4, 2028

Manufacturer

Dreve Otoplastik GmbH

Manufacturer SRN

DE-MF-000005459

Manufacturer country

Germany

Notified body

TÜV NORD CERT GmbH

Notified body SRN

0044

Notified body country

Germany

No specific devices are listed for this certificate.

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