Certificate IX 1006099-1

Certificate number

IX 1006099-1

Certificate type

Technical documentation

Certificate status

Issued

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Version

1

Certificate ID

0197IX 1006099-11

Issued

Mar 19, 2026

Valid from

Mar 19, 2026

Valid until

Feb 11, 2031

Manufacturer

77 Elektronika Műszeripari Kft

Manufacturer SRN

HU-MF-000004266

Manufacturer country

Hungary

Notified body

TÜV Rheinland LGA Products GmbH

Notified body SRN

0197

Notified body country

Germany

• Dcont ETALONIVDR Class C
  59973457DEK7V

Sterile

—

Human tissues

—

Animal tissues

—

In vitro diagnostics

—

Initial registration

Yes

New device

No

Discard allowed

No

SSCP enabled

Yes

Mechanism of scrutiny

No

Intended medical purpose

—

SPP applicable

—

Conditions applicable

No

MOS outside EUDAMED

—

QMS/MOS type

Others

No status changes or preceding certificates are recorded.