Certificate 2253382CE02

Certificate number

2253382CE02

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

03442253382CE02Rev. 0

Issued

Feb 9, 2024

Valid from

Feb 9, 2024

Valid until

Jan 1, 2028

Manufacturer

Bactiguard AB

Manufacturer SRN

SE-MF-000020790

Manufacturer country

Sweden

Notified body

DEKRA Certification B.V.

Notified body SRN

0344

Notified body country

Netherlands

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

No status changes or preceding certificates are recorded.