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Bundled Procedure Pack

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

Active European Union

Ref 900584/F08

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number184350167bpacks01FM Basic UDI-DIDate7 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  • Withdrawn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 IIb
Model / Reference
900584/F08
Primary DI / UDI-DI
08435016794520
Basic UDI-DI
184350167bpacks01FM
EMDN Code
Q021113 Ophthalmic surgery instrument kits, single-use
Device Class
Class IIb
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