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Siobal Pack

by Ajl Ophthalmic Spain EUDAMED

Ref PS5000OR

EMDN Q02030202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84351943036SL Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Siobal Pack. Aceite De Silicona + Sistema Conector De Inyección/Extracción De Aceite De Silicona
Model / Reference
PS5000OR
Primary DI / UDI-DI
08435194328234
Basic UDI-DI
84351943036SL
EMDN Code
Q02030202 Ophthalmic surgery, silicone oils, pure and combined with other substances
Device Class
Class IIb
Medical Purpose
El SIOBAL PACK está indicado para ser usado en cirugía oftálmica, en todos los casos en los que se utilice el vitreotomo para la inyección de aceite de silicona.

Manufacturer details

EUDAMED SRN
ES-PR-000000577

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 08435194328234|84351943036SL 61 fields · synced 24 Oct 2026