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Bundled Procedure Pack

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

Ref QE400328/6

EMDN Q021113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number184350167bpacks02FP Basic UDI-DIDate8 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
BUNDLE CUSTOM OPHTHALMIC PROCEDURE PACK IIa
Model / Reference
QE400328/6
Primary DI / UDI-DI
08435016724497
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 & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED c9571fec-1288-4f58-8a23-f780a44fc127 61 fields · synced 22 Oct 2026