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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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77 Elektronika Műszeripari Kft

Certificate IX 1006099-2

Rev. 1Issued
Valid until
Feb 11, 2031

Certificate IX 1006099-2 is a valid Technical documentation issued to 77 Elektronika Műszeripari Kft and registered in EUDAMED. Valid until February 11, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number
IX 1006099-2
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 1006099-21

Validity

Issued
Mar 19, 2026
Valid from
Mar 19, 2026
Valid until
Feb 11, 2031

Notified body

Notified body
TÜV Rheinland LGA Products GmbH
Notified body SRN
0197
Notified body country
Germany

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

  • ETALON Teszt
    59973457ETC8X

Documents

LanguagesEN

Manufacturer

Manufacturer
77 Elektronika Műszeripari Kft
Manufacturer SRN
HU-MF-000004266
Manufacturer country
Hungary

Covered devices

  • ETALON TesztIVDR Class C
    59973457ETC8X

Linked SSCPs

  • SSCP SSP Dcont ETALON (D71) and variants, ETALON Teszt test strip v2