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Monomanual I/A System reusable

by Bürki inno med AG EUDAMED

Active European Union

Ref SL 116 s2

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764013745P02P04X4 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
I/A System reusable
Model / Reference
SL 116 s2
Primary DI / UDI-DI
07640137451806
Direct Marketing DI
07640137451806
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000017443
Authorised representative
Bürki inno med GmbH DE-AR-000008073

From the manufacturer

Manufacturer's product page: Monomanual I/A System reusable (SAFE-LOCK I/A Coaxial System)

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