Certificate MDR.2292-2025/0006

Certificate number

MDR.2292-2025/0006

Certificate type

Quality assurance

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

2292MDR.2292-2025/00060

Issued

Apr 15, 2025

Valid from

Apr 15, 2025

Valid until

Apr 14, 2030

Manufacturer

SC SPD STAR SRL

Manufacturer SRN

RO-MF-000004404

Manufacturer country

Romania

Notified body

UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Notified body SRN

2292

Notified body country

Türkiye

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

No

Mechanism of scrutiny

No

Intended medical purpose

No

SPP applicable

No

Conditions applicable

No

MOS outside EUDAMED

—

QMS/MOS type

Others

No status changes or preceding certificates are recorded.