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Procedure Pack

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

Withdrawn Not intended for the EU market

Ref Q4015537/5

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number184350167cpacks01G8 Basic UDI-DIDate24 Nov 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
CUSTOM OPHTHALMIC PROCEDURE PACK IIa
Model / Reference
Q4015537/5
Primary DI / UDI-DI
08435016728334
Basic UDI-DI
184350167cpacks01G8
EMDN Code
Q021113 Ophthalmic surgery instrument kits, single-use
Device Class
Class IIa
Medical Purpose
Medical devices 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

Show properties
  • Sterile