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Bundled Procedure Pack

by Servicio Integral Hospitalario, S.L.U. EUDAMED

Active European Union

Ref Q406771/6

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number184350167bpacks02FP Basic UDI-DIDate8 Jan 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  • Withdrawn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
BUNDLE CUSTOM OPHTHALMIC PROCEDURE PACK IIa
Model / Reference
Q406771/6
Primary DI / UDI-DI
08435016712876
Basic UDI-DI
184350167bpacks02FP
EMDN Code
Q021113 Ophthalmic surgery instrument kits, single-use
Device Class
Class IIa
Medical Purpose
Bundle of sterile medical devices in their own individual packaging intended to be used in an ophthalmic surgical procedure. The products contained in the pack are selected by trained medical professionals who know how to use them correctly, both individually and in combination with other health products.

Manufacturer details

EUDAMED SRN
ES-PR-000011724

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Properties

  • Sterile