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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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EMS Handels Gesellschaft m.b.H.

Certificate 2024-MDR/QS-030

Rev. 0Issued
Valid until
Jun 19, 2029

Overview

Certificate number
2024-MDR/QS-030
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
22652024-MDR/QS-0300

Validity

Issued
Jun 19, 2024
Valid from
Jun 19, 2024
Valid until
Jun 19, 2029

Manufacturer

Manufacturer
EMS Handels Gesellschaft m.b.H.
Manufacturer SRN
AT-MF-000002599
Manufacturer country
Austria

Notified body

Notified body
3EC International a.s.
Notified body SRN
2265
Notified body country
Slovakia

Characteristics

Sterile
No
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa3

3 scopes

  • Neurophysiology devices - other
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa

Documents

LanguagesEN

Covered devices

  • SiennaClass IIa
    912004097CX1CT
  • Sienna UltimateClass IIa
    912004097DX1CY