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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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Edenta Etablissement

Certificate 1000183128

Issued
Valid until
Mar 26, 2030

Certificate 1000183128 is a valid Quality management system issued to Edenta Etablissement and registered in EUDAMED. Valid until March 26, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number
1000183128
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
02971000183128

Validity

Issued
Mar 27, 2025
Valid from
Mar 27, 2025
Valid until
Mar 26, 2030

Notified body

Notified body
DQS Medizinprodukte GmbH
Notified body SRN
0297
Notified body country
Germany

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 IIa8

8 scopes

  • MDN 1208 - Nichtaktive nichtimplantierbare Instrumente
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa

Manufacturer

Manufacturer
Edenta Etablissement
Manufacturer SRN
LI-MF-000011937
Manufacturer country
Liechtenstein

Covered devices

  • Polierer / ArkansasClass IIa
    ++E31216412DU
  • Diamant InstrumenteClass IIa
    ++E31216670EL
  • Diamant StreifenClass IIa
    ++E31263358FH
  • HM-/Stahl-BohrerClass IIa
    ++E31210521CQ
  • Chirurgie FräserClass IIa
    ++E31211341CT
  • Endo-InstrumenteClass IIa
    ++E31216411DS
  • Podologie SchleiferClass IIa
    ++E31217761EX

Documents

LanguagesENDE